Accidental hypothermia (AH) can occur in mild-to-severe cases; however, its management is crucial in severe cases as it can cause ventricular fibrillation and lead to death. Among various rewarming therapies for AH, endovascular catheter rewarming has been the focus of recent studies as a minimally invasive alternative to invasive internal rewarming, such as extracorporeal membrane oxygenation (ECMO). However, no study has demonstrated the efficacy and safety of endovascular catheter rewarming therapy. This study aimed to validate the efficacy and safety of endovascular catheter rewarming for patients with AH.

The intensive care with endovascular catheter rewarming in accidental severe hypothermia (ICE-CRASH II) study is a multicentre, randomised study of patients with AH. This study will include patients with AH (age ≥65 years, core temperature

This study was approved by the Hokkaido University Certified Review Board (approval number: 024-00013). Written informed consent will be obtained from all the participants or their legally acceptable representatives. The results will be disseminated through publications and presentations.

Japan Registry of Clinical Trials (jRCT1012240051).

With an ageing population, prevention of frailty among older adults has become a critical public health issue. Dietary habits are one of the essential components in frailty prevention, which involves promoting changes in dietary behaviours, such as including dietary variety. However, community-level health promotion interventions face significant challenges, including limited spatial access to food, which is important as it is not easy to change the behaviour of older adults. The dissemination of community-level health promotion interventions targeting dietary behavioural changes among older adults remains unclear. Therefore, this study aimed to evaluate the effects of supermarket-based health promotion interventions on dietary variety among older Japanese adults.

This study is a cluster non-randomised parallel-group comparative trial involving 15 supermarkets in the Yamanashi and Nagano Prefectures, Japan. Seven supermarkets will be assigned to the intervention group and eight to the control group. The intervention group will receive a health promotion programme consisting of three components to enhance dietary diversity: information, education and support delivery. The intervention design incorporates social marketing strategies, and programme evaluation will be conducted concurrently. Data, including the Dietary Variety Score (DVS) for the primary outcome, will be collected through postal and electronic surveys at baseline and at 1, 2 and 3 years, with the 3-year follow-up serving as the primary endpoint for effectiveness evaluation. Statistical analyses will use a generalised linear mixed model, focusing on changes in the DVS as the primary outcome. Sensitivity and subgroup analyses will be performed to assess the generalisability of the findings.

The Tokyo Metropolitan Institute for Geriatrics and Gerontology Research Ethics Committee has approved the research protocol (approval number: R23-116). The results will be disseminated through conference presentations and publication in peer-reviewed international journals.

UMIN000056023.

Temperature control is a fundamental intervention for neuroprotection following resuscitation from cardiac arrest. However, evidence regarding the efficacy of hypothermia in post-cardiac arrest syndrome (PCAS) remains unclear. Retrospective studies suggest that the clinical effectiveness of hypothermia may depend on the severity of PCAS. The R-CAST OHCA trial aims to compare the efficacy of hypothermia versus normothermia in improving 30-day neurological outcomes in patients with moderately severe PCAS following out-of-hospital cardiac arrest.

The multicentre, single-blind, parallel-group, superiority, randomised controlled trial (RCT) is conducted with the participation of 35 emergency and critical care centres and/or intensive care units at academic and non-academic hospitals. The study enrols moderately severe PCAS patients, defined as those with a revised post-Cardiac Arrest Syndrome for induced Therapeutic Hypothermia score of 5.5–15.5. A target number of 380 participants will be enrolled. Participants are randomised to undergo either hypothermia or normothermia within 3 hours after return of spontaneous circulation. Patients in the hypothermia group are cooled and maintained at 34°C until 28 hours post-randomisation, followed by rewarming to 37°C at a rate of 0.25°C/hour. Patients in the normothermia group are maintained at normothermia (36.5°C–37.7°C). Total periods of intervention, including the cooling, maintenance and rewarming phases, will occur 40 hours after randomisation. Other treatments for PCAS can be determined by the treating physicians. The primary outcome is a favourable neurological outcome, defined as Cerebral Performance Category 1 or 2 at 30 days after randomisation and compared using an intention-to-treat analysis.

This study has been approved by the Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee (approval number: R2201-001). Written informed consent is obtained from all participants or their authorised surrogates. Results will be disseminated via publications and presentations.

jRCT1062220035.