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Dapagliflozin for cardiorenal protection after intensive care unit discharge: a protocol for a randomised controlled trial evaluating dapagliflozin at ICU discharge for cardiorenal protection (DAPA-ICU)

Por: Depret · F. · Chousterman · B. · Roger · C. · Garnier · M. · Lalande · R. · Kerforne · T. · Rouve · E. · Lukaszewicz · A.-C. · Ouattara · A. · Merdji · H. · Turbil · E. · Bouhemad · B. · Quenot · J.-P. · Delbove · A. · Levrat · Q. · Jully · M. · Legriel · S. · Bougouin · W. · Klouche · K.
Introduction

Patients discharged from intensive care units (ICUs) are at high risk of adverse long-term outcomes including cardiovascular and/or renal events and a 1-year mortality of approximately 22%. Plasma biomarkers measured at ICU discharge have demonstrated strong prognostic value, with elevated cardiac or renal biomarkers identifying patients at particularly high risk of poor outcomes. Sodium-glucose cotransporter 2 inhibitors are now widely recognised for their cardioprotective and nephroprotective effects in chronic conditions such as type 2 diabetes, heart failure or chronic kidney disease. These agents improve both morbidity and mortality across a range of high-risk populations. We hypothesise that a therapeutic strategy aimed at preventing the progression of cardiovascular and/or renal injury following ICU discharge may improve long-term outcomes in ICU survivors.

Method and analysis

This is a multicentre, double-blind, randomised, placebo-controlled clinical trial conducted across 16 teaching and non-teaching ICUs in France. We will enrol 600 adult patients (18 years of age or older) who have received mechanical ventilation and/or vasopressors for at least 24 hours during their ICU stay, and who meet at least one of the following criteria at ICU discharge: N-terminal pro-B-type natriuretic peptide (NT-proBNP) >800 pg/mL or BNP >90 ng/L, an estimated glomerular filtration rate between 25 and 90 mL/min/m². Eligible patients will be randomised in a 1:1 ratio to receive either dapagliflozin (10 mg once daily) or a matching placebo for a duration of 1 year. The primary outcome is a composite endpoint assessed at 1 year after randomisation, comprising: all-cause mortality, unscheduled hospitalisation for acute heart failure and decrease in renal function. Feasibility will be assessed based on patient and clinical acceptability and recruitment performance, including enrolment rates across participating centres.

Ethics and dissemination

This study has been approved by the Institutional Review Board (CPP Ile-de-France 5). Written informed consent will be obtained from all participants prior to enrolment and the initiation of any study-related procedures. Dapagliflozin is a widely available medication with an established safety profile. If proven effective, it would represent a readily deployable strategy to improve long-term outcomes in ICU survivors. The study is described in accordance with the Standard Protocol Items: Recommendations for Interventional Trials framework, and key design features and methodological decisions are outlined accordingly. DAPA-ICU aims to evaluate the efficacy of dapagliflozin in cardiorenal protection among critically ill patients following ICU discharge. The main trial results will be submitted for publication in a peer-reviewed journal as soon as they become available after final analysis.

Trial registration number

NCT07025629.

Impact of increased resident preparation time on internal medicine rounds in a tertiary teaching hospital: a time-motion study with a before-and-after comparison

Por: Garnier · A. · Cominetti · F. · Monti · M. · Marques-Vidal · P. · Bastardot · F. · Vollenweider · P. · Waeber · G. · Castioni · J. · Gachoud · D. · Kraege · V.
Objectives

To determine whether postponing daily medical rounds to provide additional preparation time for residents reduces round duration and alters time allocation during rounds, with the hypothesis that increased preparation leads to more efficient rounds without reducing patient contact.

Design

Time and motion study with a before-and-after comparison.

Setting

Internal medicine division of Lausanne University Hospital, a Swiss tertiary teaching hospital.

Participants

75 residents; 60% women; mean age of 29.6 years and 3.0 years of training.

Intervention

In 2017, the daily work schedule was reorganised by postponing rounds from 09:00 to 10:00 and moving educational sessions to the afternoon, thereby freeing 90 min to prepare patient cases before rounds.

Primary and secondary outcome measures

The primary outcome was the duration of rounds and the proportion thereof spent with patients, using computer systems or in discussion with colleagues. Secondary outcomes included the detailed distribution of resident activities during the officially scheduled round period, particularly time dedicated to supervision, teaching and administrative tasks.

Results

Round duration decreased from 142 min per shift (95% CI 128 to 156) in 2015 to 112 min (95% CI 101 to 124) in 2018 (p=0.001). The proportion of round time spent directly with patients remained stable at 47%. Computer use during rounds decreased from 43% to 32% (p

Conclusions

Postponing rounds to allow more preparation time was associated with shorter, possibly more efficient rounds, reduced computer use in patient presence and increased supervision and teaching.

Trial registration number

ISRCTN69703381, https://doi.org/10.1186/ISRCTN69703381 (registration date: 24 April 2018).

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