Conectar
The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.
We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.
This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.
Recently, legal questions have increasingly arisen in intensive care medicine (ICM), especially when it comes to end-of-life decisions. Still, for Europe, there is not much evidence about doctors’ situational legal knowledge and legal education during medical studies and further qualification. The present study was initiated to analyse these hitherto unexplored aspects in Germany.
A quantitative online survey has been performed among German intensive care physicians. The voluntary participants of the anonymous online survey were asked to answer legal questions related to end-of-life policies, informed consent, surrogate decision making or advance directives. We tested pure factual knowledge in five questions. The other five questions tested situational knowledge using case vignettes. Every question could be answered with ‘yes’, ‘no’ or ‘do not know’. Furthermore, the participants were asked to assess their subjective certainty on a Likert scale and to provide information about their professional experience (PE) and qualification.
All members of the two German professional societies for anaesthesiology who work in ICM were asked to take part in the survey.
952 completed questionnaires were analysed. 86% of the participants were specialists, and 56% held the additional qualification in ICM. 78% had more than 10 years of general clinical experience, and 62% had more than 5 years of experience in ICM.
On average, the participants answered the five facts–questions in 90.8% correctly. However, only 73.6% of the five case vignettes were answered correctly. Specialists, physicians with a lot of PE or physicians holding the additional qualification in ICM did not perform better than assistants or physicians with little PE.
German intensive care physicians have relevant gaps regarding situational legal knowledge, which are independent of their PE or qualification and persist. This may be due to difficulties in interpretation and implementation of law. Since these knowledge gaps can lead to liability and criminal prosecution, these gaps should be closed through awareness-raising and continuous education.
Post-intensive care syndrome affects up to 70% of adult intensive care unit (ICU) survivors, with ICU-acquired weakness contributing substantially to long-term disability. Despite evidence supporting early and structured rehabilitation to enhance physical recovery, targeted upper-limb rehabilitation approaches in the ICU remain comparatively underexplored. This scoping review will map and summarise existing evidence on upper-limb weakness and rehabilitation strategies delivered by healthcare professionals for critically ill adults.
This scoping review protocol has been developed in accordance with the Joanna Briggs Institute methodology for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews, ensuring transparent and comprehensive reporting. Searches will be conducted in MEDLINE (Ovid), CINAHL (EBSCO), Embase, Scopus and the Cochrane Central Register of Controlled Trials (CENTRAL). The search will include studies published between March 2009 and August 2025, aligning with National Institute of Clinical Excellence (NICE) Guideline CG83 (2009), which marked a major policy shift in ICU rehabilitation practice. Quantitative data will be summarised descriptively (eg, frequencies and proportions), while qualitative data will undergo thematic synthesis to identify patterns in experiences, perceptions and implementation of upper-limb rehabilitation. Grey literature (eg, OpenGrey and relevant conference proceedings) will also be screened to reduce publication bias. Rayyan AI software will be used to manage citation screening and reviewer collaboration; no artificial intelligence-assisted decision tools will be used to determine study inclusion.
As this review will synthesise previously published data, ethical approval is not required. Results will be disseminated through peer-reviewed publication, conference presentations and open-access platforms. Findings from this review will inform the development of evidence-based ICU rehabilitation guidelines and highlight priorities for future research to improve upper-limb recovery in critically ill adults.
Open Science Framework (osf.io/j86nf).
Hospital patients are at an increased risk of falls, which are a significant safety concern within healthcare settings.1 Understanding how the COVID-19 pandemic has influenced fall risks is essential for identifying key factors that could inform future fall prevention strategies.2 This scoping review aims to explore the barriers and challenges associated with preventing inpatient falls in the context of the post-COVID-19 environment.
The methodology for this scoping review follows the framework established by Arksey and O’Malley. A comprehensive literature search will be conducted using specific keywords to identify relevant published studies. Searches will be performed across selected electronic databases, including PubMed/MEDLINE, CINAHL, Scopus, ProQuest and Web of Science, covering publications from 2014 to 2024. This review will focus on a global perspective. Two authors will independently screen titles and abstracts to identify potential studies for inclusion. Studies meeting the inclusion criteria will be retrieved for full-text review, and their references will be assessed for relevance using the same criteria. The PRISMA flow diagram will guide the review process. Data will be extracted, analysed and charted according to categories from the selected publications.
This scoping review will provide a comprehensive overview of the barriers and challenges in preventing inpatient falls in the post-pandemic context. The findings will be disseminated through submission for publication in a scientific journal.
This scoping review protocol is registered with Open Science Framework (OSF) available at https://osf.io/.
Falls are highly prevalent among individuals with dementia, largely due to the cognitive and physical impairments associated with the condition. Understanding the barriers and challenges to fall prevention in community-dwelling individuals with dementia is essential for developing tailored strategies that address their unique risks. Despite the existing evidence on fall prevention in older adults, few reviews specifically examine the obstacles faced by persons with dementia and their caregivers in community settings. This scoping review, therefore, aims to map the barriers and challenges to preventing falls among community-dwelling individuals with dementia.
This review will follow Arksey and O’Malley’s five-stage framework and be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Extension for Scoping Reviews checklist. Six electronic databases (PsycINFO, PubMed, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Scopus and Embase) will be searched for relevant studies published between 2014 and 2024. Grey literature sources, including dissertations and conference proceedings, will also be included. Data will be charted and synthesised thematically to provide an overview of barriers and contextual factors influencing fall prevention. The study commenced in August 2025 and is expected to be completed by February 2026.
As this review involves the analysis of existing literature, ethical approval is not required. Findings will be disseminated through peer-reviewed publications, conference presentations and summaries tailored for healthcare providers and caregiver groups.
The protocol is registered with the Open Science Framework: https://osf.io/gnw47/(dataset).
Patients who survive admission to intensive care unit (ICU) for critical illness are at high risk of developing muscle atrophy and weakness, commonly diagnosed as ICU-acquired weakness (ICUAW). The development of ICUAW is closely linked to long-term symptoms and impairments known as post-intensive care syndrome (PICS). Despite heightened recognition of impairments, there is limited research supporting effective interventions to improve muscle and physical outcomes after hospital discharge. Prior to developing and testing interventions for ICU survivors, it is imperative to understand the trajectory of muscle and physical function recovery following an ICU stay. The purpose of this study is to longitudinally investigate skeletal muscle health and physical function outcomes after ICU admission.
This protocol describes a single site, prospective, observational study in adult patients who have survived a critical illness (ie, sepsis or acute respiratory failure). Patients will participate in a battery of testing including primary outcomes: muscle power and physical function; and secondary outcomes: muscle strength, muscle size, endurance and physical activity (by accelerometry) at hospital discharge and 3, 6, and 12 months post-discharge. A subset of patients will participate in muscle biopsy and venipuncture. To examine if the trajectory of recovery predicts primary outcomes, we will perform multivariate linear regression models in 150 evaluable patients. To examine differences in molecular and cellular outcomes in plasma and muscle tissue, a control group of community-dwelling adults without history of an ICU stay will be enrolled as a comparator group. Enrolment started on 18 October 2022 with an estimated completion date of 1 August 2027.
This protocol was approved by the University of Kentucky Office of Research Integrity Medical Internal Review Board (# 77407), with patients providing informed written consent. We anticipate our findings to establish recovery trajectories, improving the classification of patients who experience sustained physical disability. Improved identification of recovery trajectories of muscle and physical function enables future studies to employ an individually targeted rehabilitation approach, that is, precision medicine, with the goal of improving patient outcomes. The cellular findings will support the development of novel interventions specifically designed for detecting underlying mechanisms. We intend to disseminate findings to patients, healthcare professionals, the public and other relevant groups via conference presentations and manuscripts without publication restrictions.
The purpose of this review is to identify the theoretical framework of implementation science in the intensive care unit (ICU), the determinants affecting implementation results, the intervention guided by a theoretical framework and the assessment of implementation effectiveness based on implementation science to guide further advancement of the implementation of evidence in the field of ICU.
The scoping review was conducted in accordance with the Joanna Briggs Institute (JBI) Scoping Review Methodology Group’s guidance and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. The study protocol was registered with the International Prospective Registry of Systematic Reviews on 15 December 2024 (registration number: CRD42024614246).
We searched the following databases and sources: PubMed, Web of Science, Cochrane Library and EBSCO.
We included studies exploring the implementation science in the ICU that were published in English language.
Two researchers conducted the literature search by referring to the search strategies, and one researcher removed duplicates using EndNote. Two independent investigators screened the retrieved studies based on their titles and abstracts using eligibility criteria. Subsequently, the same two researchers conducted a full-text screening.
13 articles were included: 8 qualitative studies, 3 mixed studies, 1 quasi-experimental study and 1 prospective observational study. Regarding the implementation of the theoretical framework for research, seven studies applied the consolidated framework for implementation research (CFIR), two studies applied the research implementation in health services framework (i-PARIHS) and one each of the research into the translating research into practice model, the exploration, preparation, implementation, sustain, the reach, effectiveness, adoption, implementation and maintenance model and the behaviour change wheel. The CFIR was the most applied in the ICU, followed by the i-PARIHS. The literature demonstrated how implementation science is used and how it can reduce the gap between evidence and practice.
Strategies to support the implementation of accelerated evidence-based practice in the ICU are important, and more researchers need to conduct implementation science studies of the ICU to facilitate the translation of evidence and improve the quality of nursing practice in the future.
Patients receiving extracorporeal membrane oxygenation (ECMO) for severe acute respiratory failure (SARF) often experience significant challenges with airway clearance due to disease severity, ultra-protective ventilation strategies and suppression of mucociliary and cough mechanisms. Extremely low tidal volumes and minimal flow rates further hinder secretion mobilisation. Despite increasing global use of ECMO, there is currently no synthesis of evidence describing airway clearance practices, their physiological rationale or outcomes in this population.
This scoping review aims to explore the extent and nature of evidence on airway clearance interventions in invasively ventilated adult patients receiving ECMO for SARF. Specific objectives include mapping the types of interventions described and specific parameters, their intended physiological effects, reported outcomes and safety considerations.
This scoping review will be conducted in accordance with the Joanna Briggs Institute methodology and reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A comprehensive search will be undertaken across Embase, Ovid Emcare, Ovid Medline, CINAHL and grey literature sources including TRIP and Google Scholar. Eligible studies will include original data on airway clearance interventions in adult patients (≥16 years) receiving ECMO for SARF. Studies focused on paediatric populations, extracorporeal carbon dioxide removal, or solely cardiac ECMO will be excluded.
Two independent reviewers will screen titles, abstracts and full texts, extract data using a piloted tool and summarise findings using descriptive statistics and narrative synthesis. Basic qualitative content analysis will support mapping of interventions including parameters, their physiological and clinical rationale, and reported outcomes including adverse effects.
As this study involves a review of existing literature and does not include collection of primary data, ethical approval is not required. Findings will be disseminated through publication in a peer-reviewed journal and presentation at relevant academic and professional meetings. The results are expected to highlight variations in practice and provide a foundation for future research aimed at optimising respiratory care and improving outcomes for patients receiving ECMO for SARF.
osf.io/ptfr7.
A successful extubation process is critical for the future health outcomes of paediatric patients, as it tests the functioning of the respiratory system without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety or discomfort in patients, which may sometimes lead to an increased likelihood of reintubation. Music-based interventions and therapies have been shown to be effective in reducing anxiety and stress levels in ventilated patients in the paediatric intensive care unit (PICU), but studies evaluating the effect of music therapy during the extubation process in the PICU are scarce.
This is a pragmatic multicentre randomised clinical trial with two parallel arms. The intervention group will receive standard care + music therapy during the extubation process, and the control group will receive standard care alone. The main outcome measure is heart rate, which will be measured every minute for 5 min pre-extubation, during the extubation process and up to 10 min postextubation. Secondary outcome measures are: oxygen saturation, respiratory rate, blood pressure and heart rate variability. A total of 82 patients will be randomised.
This study was approved by the Research Ethics Committee of the Fundación Universitaria Sanitas (CEIFUS 1356-24, date of approval: 3 May 2024). All parents or legal guardians of patients will sign a written informed consent, and if applicable, assent from participants will be sought. The results will be disseminated through publications in peer-reviewed journals, conferences and presentations at the hospitals’ clinical committees.
Version 1.0, 18 December 2024.
NCT06591533, trial registration date: 10 September 2024.
This study aimed to investigate the impact of socioeconomic status and country of origin on COVID-19 outcomes in Swedish intensive care units (ICUs), hypothesising that these factors are independently associated with 90-day mortality.
Registry-based cohort study.
Swedish ICUs, from 6 March 2020 to 31 December 2022.
Adults (≥18 years) with confirmed SARS-CoV-2 infection and acute hypoxaemic respiratory failure. A total of 5833 patients were included in the multivariable model.
Not applicable.
The primary outcome was 90-day mortality. Secondary outcomes included 1-year mortality and ventilator and renal replacement therapy-free days within 60 days post-ICU admission.
Non-European country of origin was independently associated with higher 90-day and 1-year mortality adjusted OR (aOR) 1.34 [95% CI 1.13 to 1.61], p=0.001, aOR 1.26 [95% CI 1.01 to 1.5], p=0.01, respectively. Socioeconomic variables did not significantly impact mortality or organ support-free days. Other predictors of 90-day mortality included age, sex, chronic heart and lung disease, Simplified Acute Physiology Score 3 score, immunosuppression, time in hospital prior to ICU admission, pandemic wave and admission Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen-ratio.
The study identified significant disparities in COVID-19 outcomes based on country of origin, with non-European patients facing higher mortality risks. These findings could challenge the notion of equitable healthcare in Sweden and underscore the need for further research into systemic inequalities.
Sepsis is a life-threatening disease caused by a deregulated response to infection. This study aimed to investigate the linear and non-linear relationships between ionised calcium levels and 28-day mortality in patients with sepsis in the intensive care unit (ICU) and to generate hypotheses regarding laboratory index testing and calcium supplementation strategies.
A retrospective cohort study.
Adult patients admitted to the ICU, using data extracted from the Medical Information Mart for Intensive Care IV (MIMIC-IV) database.
A total of 17 955 adult patients with sepsis, defined according to the sepsis-3 criteria, were included. Patients lacking ionised calcium (iCa) data were excluded.
The exposure variable was iCa level measured within the first 24 hours of ICU admission, and the primary outcome was 28-day all-cause mortality. Covariates included demographics, vital signs, comorbidities, infection sites, organ support and medication use. Multivariable logistic regression models were applied with stepwise adjustment. Non-linear associations were assessed using generalised additive models (GAM) and two-piecewise linear regression. Sensitivity analyses using iCa quartiles and subgroup analyses stratified by Sequential Organ Failure Assessment (SOFA) score were also performed.
The overall 28-day mortality rate was 18.3%. After full adjustment, patients in quartiles Q2–Q4 had significantly lower mortality risks than those in Q1 (P for trend 0.05).
The relationship between ionised calcium and 28-day mortality in patients with sepsis showed a U-shaped curve with an inflection point of 1.16 mmol/L, which is in the range of mild hypocalcaemia.
Dysregulated immunity may account for an increased risk of infection and other adverse outcomes among frail hospitalised persons. The primary objective of this study is to examine whether baseline frailty is associated with the risk of developing ventilator-associated pneumonia (VAP) or other intensive care unit (ICU)-acquired infections among invasively ventilated adults. Additional objectives are to examine the relationship between frailty and hospital length of stay, discharge to a long-term care facility and vital status. We hypothesise that persons with frailty compared with others would have an increased risk of VAP and other infections, a longer hospital stay, higher probability of discharge to a long-term care facility and higher mortality.
This is a preplanned secondary analysis of the PROSPECT trial (
Participating hospital research ethics board approved the PROSPECT trial and data collection. The protocol for this study was approved by the Hamilton Integrated Research Ethics Board on 20 August 2015 (Project ID:19128). This study will identify whether frailty is associated with risk of VAP and other healthcare-associated infections in invasively ventilated patients, adjusted for other baseline factors. Results may be useful to patients, their caregivers, clinicians and the design of future research. Findings will be disseminated to investigators at a meeting of the Canadian Critical Care Trials Group. We will present study results at an international conference in the fields of critical care and infectious diseases, to coincide with or precede open-access peer-review publication. To aid knowledge dissemination, we will use a variety of formats. For example, for traditional and social media, we will create two different visual abstracts and infographics of our results suitable to share on clinician-facing and public-facing platforms.
Palliative and end-of-life care in the intensive care unit (ICU) is crucial for improving the quality of life of critically ill patients. However, no consensus exists on the most effective quality indicators (QIs) for assessing this care. This systematic review aims to identify and analyse the characteristics of QIs used in palliative and end-of-life care for ICU patients.
The Preferred reporting items for systematic review and meta-analysis 2020 guidelines will conduct this systematic review to ensure methodological transparency and rigour. A comprehensive literature search will be conducted across multiple databases, including PubMed, MEDLINE, EMBASE, Scopus, Google Scholar, ProQuest, EBSCOhost, ScienceDirect and BASE. Studies published up to 30 March 2025, will be included. The quality of indicators will be assessed using the appraisal of indicators through research and evaluation tool, and the characteristics of QIs will be analysed using the Donabedian model of quality. Data synthesis will include thematic analysis.
Ethical approval is not required as this study does not involve human participants. Findings will be disseminated through peer-reviewed publications and conference presentations.
CRD42024513075.
Deep vein thrombosis (DVT) in critically ill patients is often undetected. However, it is unclear whether ultrasound surveillance for early detection of DVT in high-risk medical-surgical intensive care unit (ICU) patients improves patients’ outcomes. The DETECT trial (Diagnosing deep-vein thrombosis early in critically ill patients) evaluates the effect of twice-weekly bilateral lower limb ultrasound compared to usual care on 90-day mortality of critically ill adult patients admitted to medical, surgical and trauma ICUs.
The DETECT trial is an international, parallel-group, open-label, randomised trial, which will recruit 1800 critically ill adults from over 14 hospitals in Saudi Arabia and Kuwait. Eligible patients will be allocated to twice-weekly bilateral lower limb ultrasound or usual care. The primary outcome is 90-day mortality. Secondary outcomes include lower limb proximal DVT, pulmonary embolism and clinically important bleeding. The first patient was enrolled on 21 March 2023. As of 8 April 2025, 711 patients have been enrolled from 14 centres in Saudi Arabia and Kuwait. The first interim analysis was conducted on 14 May 2025. We expect to complete recruitment by December 2026.
Institutional review boards (IRBs) of each participating institution approved the study. We plan to publish the results in peer-reviewed journals and present the findings at international critical care conferences.
Clinicaltrials.gov: NCT05112705, registered on 9-11-2021.
Many patients who are extubated after receiving mechanical ventilation for acute respiratory failure experience extubation failure (ie, require reintubation hours to days after extubation). High-quality evidence shows that extubating patients directly to non-invasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC), rather than conventional low-flow oxygen, can prevent extubation failure. These guideline-recommended interventions, however, require care coordination involving multiple intensive care unit (ICU) team members and are infrequently used. Interprofessional education (IPE), which teaches members of multiple professions together, could effectively address this implementation gap in complex, team-based, critical care settings, particularly when paired with a customisable protocol.
This batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness–implementation trial will test three hypotheses: (1) when compared with traditional online education (OE), IPE increases implementation of preventive postextubation respiratory support, (2) the benefits of IPE are increased when paired with a clinical protocol and (3) preventive postextubation NIV for high-risk patients and preventive postextubation HFNC for low-risk patients reduce in-hospital mortality when compared with conventional postextubation oxygen therapy. The trial will recruit 24 clusters made up of one or more ICUs that care for at least 100 mechanically ventilated patients per year in a large multihospital health system in the USA. All clusters will receive OE, IPE and a clinical protocol, with timing determined by randomisation. We will also randomise half of the clusters to education promoting postextubation NIV for patients at high risk of extubation failure and preventive, postextubation HFNC for patients at lower risk, whereas the other half will be randomised to education promoting postextubation HFNC for all eligible patients. We will include all patients who are invasively mechanically ventilated for at least 24 hours. The primary implementation endpoint is the rate of use of postextubation NIV or HFNC among eligible participants. The primary clinical endpoint is in-hospital mortality truncated at 60 days from intubation.
This study was approved by the institutional review board of the University of Pittsburgh and an independent data safety monitoring board. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. We will disseminate results to participating healthcare providers, through publication in a peer-reviewed medical journal and via presentations at international conferences.
Stroke volume is a major determinant of tissue perfusion and, therefore, a key parameter to monitor in patients with haemodynamic instability and hypoperfusion. Left ventricular outflow tract (LVOT) velocity-time integral (VTI) measurement using pulsed-wave Doppler is widely used as an estimation of stroke volume and should be a competence required for every intensive care unit (ICU) physician. Artificial intelligence (AI) applied to ultrasound facilitates the acquisition of adequate images. The aim of the present study is to evaluate the interchangeability of LVOT VTI measurements obtained by minimally trained operators and expert physicians, both guided by AI.
This is a prospective multicentre randomised controlled trial. ICU patients in whom fluid administration is considered necessary will be included. A minimally trained operator and an expert will independently measure LVOT VTI, guided by the UltraSight AI software to obtain the best five-chamber view, before and after a 250 mL fluid challenge. The order of acquisition between each operator will be randomised. 100 patients will be included.
The primary endpoint is the relative difference in LVOT VTI between operators. Secondary outcomes include the concordance of the therapeutic decision made by the blinded physician in charge of the patient based on the measures obtained by each operator, and the agreement between absolute values of LVOT VTI obtained by minimally trained and expert operators.
The study has been reviewed and approved by a regional ethics committee (Comité de Protection des Personnes—Ile de France II—n°24.00671.000291). An information note will be given to the participant before he or she participates in the study. The present study will be disseminated through peer-reviewed publications and academic and medical conferences.
Sepsis is defined as a dysregulated host response to infection, associated with high morbidity and mortality rates globally. Recent studies have indicated that increasing ketone levels may be beneficial for patients with sepsis. Existing research has established the feasibility, effectiveness and safety of the ketogenic diet in sepsis patients. This study aims to further clarify the organ-protective effects of a ketogenic diet in sepsis patients through a multicentre randomised controlled trial.
This is a multicentre, prospective, randomised controlled trial conducted in five intensive care units (ICUs) in China. The intervention group will receive a ketogenic diet, while the control group will receive standard enteral nutrition. The primary outcome is the protective effect of the ketogenic diet on the heart, kidneys and liver in septic patients. Secondary outcomes include ICU and hospital mortality rate, ICU and hospital length of stay, rate and duration of mechanical ventilation, blood glucose levels and the rate of renal replacement therapy.
This study has been approved by the Ethics Committee of Northern Jiangsu People’s Hospital Affiliated to Yangzhou University (No. 2024ky290-2). Upon completion, the researchers will disseminate the results to the public through publication in peer-reviewed journals
Chinese Clinical Trial Registry in December 2024 (Registration Number: ChiCTR2400093805).
There is a lack of evidence on the efficacy of extracorporeal blood purification (EBP) to reduce the mortality rate in septic shock. We have designed the EABPSS (Efficacy of Adaptive Blood Purification for Septic Shock) study to confirm whether adaptive blood purification (ABP) intervention could confer a clinical benefit.
In this multicentre, open-label, randomised controlled trial, we are recruiting a total of 276 patients with septic shock. Eligible patients who provide informed consent will be randomly assigned in a 1:1 ratio to either the control group or the intervention group. Patients in the control group will receive standard care according to the Surviving Sepsis Guidelines. Patients in the intervention group will receive two 6-hour sessions of ABP treatment within 24 hours of enrolment, based on standard care. ABP is a novel, adaptive EBP strategy proposed by our research team. Specifically, for patients with septic shock who do not require renal replacement therapy (RRT), plasmafiltration-adsorption (PFAD) will be used alone, and for patients with septic shock and acute kidney injury meeting RRT indications, a combination of PFAD–RRT will be employed. The primary endpoint of this study is all-cause mortality at 90 days after enrolment. Secondary endpoints of the study include the declining proportion of serum cytokines such as tumour necrosis factor-α (TNF-α), IL-4, IL-6, IL-8, IL-10 and high-mobility group box 1 within 24 hours after enrolment. Additionally, the study will evaluate the improvement of the Sequential Organ Failure Assessment score on day 7 postenrolment, as well as the 30-day mortality rate.
The study was approved by the respective ethical committees of the participant centres, including: Ethics Committee of Beijing Chaoyang Hospital, Capital Medical University (2024-KE-348); Ethics Committee of PLA General Hospital (S2024-716-01); Ethics Committee of China–Japan Friendship Hospital (2024-KY181); Clinical Research Ethics Committee of Peking University First Hospital (2024YAN258-001); Ethics Committee of Beijing Hospital (2024BJYYEC-KY106-02); Ethics Committee of Air Force Medical Center, PLA (KONGTE2024-29-PJ01); Ethics Committee of Beijing Jishuitan Hospital, Capital Medical University (JILUN(K2023)(370)-00). The findings of the study will be disseminated in peer-reviewed journals and presented at national and international conference presentations.
Hypoxaemic acute respiratory failure (ARF) in intensive care unit (ICU) patients is associated with high mortality. Three main devices are used to provide oxygen to hypoxaemic ARF patients: non-invasive ventilation (NIV), high-flow nasal cannula oxygen (HFNO) and standard oxygen (first-attempt device in usual care). To date, no multicentre randomised controlled study has compared NIV and HFNO to standard oxygen with day 28 mortality rate as primary outcome in hypoxaemic ARF in non-selected patients. Our hypothesis is that NIV and/or HFNO is superior to standard oxygen to reduce day 28 mortality rate in hypoxaemic ARF.
The Key oxygenation Interventions in Surgical and non-Surgical patients (KISS) trial is an adaptive investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system–based randomisation. Patients with hypoxaemic ARF were randomly assigned to one of three groups: the ‘NIV-group’ to receive curative NIV combined with HFNO delivered between NIV trials, or the ‘HFNO’ group to receive HFNO alone, or the ‘standard oxygen-group’ to receive oxygen therapy alone.
The primary endpoint is day 28 all-cause mortality. The main secondary endpoint is intubation rate at day 28. The exploratory endpoints are intubation rates at day 3 and day 7; oxygenation up to day 7; need for other rescue oxygen therapy up to day 7; ICU and hospital length of stay; and mortality rates in ICU, hospital and at day 90.
The main objective is to assess if NIV and/or HFNO is superior to standard oxygen to reduce day 28 mortality rate in hypoxaemic ARF. Additional comparisons between predefined stratum following randomisation will be performed: (1) medical versus postoperative admissions, (2) among medical (immunocompromised vs non-immunocompromised) and (3) among postoperative (abdominal vs cardio-thoracic).
An adaptive design will be used. Two interim analyses will be performed after 700 and 1400 included patients among the 2100 planned.
The study project has been approved by the appropriate ethics committee ‘Comité-de-Protection-des-Personnes Sud-Est V-23-CHUM-01 Cat2 2022-A02761-42/1’. Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If NIV and/or HFNO reduce the mortality at day 28, NIV and/or HFNO could be proposed to become one of the first-line therapies in hypoxaemic ARF patients.
Prognosis estimation is the basis for establishing the personal interventions in sepsis patients. Serum biomarkers are potential tools for predicting the outcomes of sepsis patients admitted to the intensive care unit (ICU). Here, we plan to perform a prospective study to investigate the prognostic value of serum biomarkers. We named this study Hospital Outcome of Host Heterogeneity, Organ dysfunction and Trajectory in sepsis (HOHHOT).
This prospective cohort study is being performed in several hospitals in the Inner Mongolia Autonomous Region between 2025 and 2027. The inclusion criteria were adult sepsis patients admitted to the ICU. A serum specimen will be collected at the onset of sepsis and stored at –80°C for future use. The endpoint of the HOHHOT study includes, but is not limited to, hospital outcome (eg, mortality, occurrence of organ dysfunction, treatment response and the progression of sepsis). We will analyse the predictive value of serum biomarkers for outcomes using a receiver operating characteristic curve and decision curve analysis. The association between baseline characteristics and serum biomarkers will be estimated using a logistic regression model, net reclassification index and integrated discriminatory index. We will also construct some predictive models using machine learning algorithms.
The HOHHOT study has been approved by the Ethics Committee of the Affiliated Hospital of Inner Mongolia Medical University (NO: KY2025005). The findings derived from the HOHHOT study will be submitted to international academic journals.
Chinese Clinical Trial Registry (ChiCTR2500100770); pre-results.
FreshRSS 