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.

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.

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.

NCT07025629.

Students enrolling in higher education often adopt lifestyles linked to worse mental health, potentially contributing to the peak age onset of mental health problems in early adulthood. However, extensive research is limited by focusing on single lifestyle behaviours, including single time points, within limited cultural contexts, and focusing on a limited set of mental health symptoms.

The UNIversity students’ LIFEstyle behaviours and Mental health cohort (UNILIFE-M) is a prospective worldwide cohort study aiming to investigate the associations between students’ lifestyle behaviours and mental health symptoms during their college years. The UNILIFE-M will gather self-reported data through an online survey on mental health symptoms (ie, depression, anxiety, mania, sleep problems, substance abuse, inattention/hyperactivity and obsessive/compulsive thoughts/behaviours) and lifestyle behaviours (ie, diet, physical activity, substance use, stress management, social support, restorative sleep, environment and sedentary behaviour) over 3.5 years. Participants of 69 universities from 28 countries (300 per site) will be assessed at university admission in the 2023 and/or the 2024 academic year and followed up for 1, 2 and 3.5 years.

The study was first approved at a national level in Brazil (CAE:63025822.8.1001.5346). Study sites outside Brazil obtained additional ethics approval from their institutions using the main approval. Results from the UNILIFE-M cohort will be disseminated through scientific publications, presentations at scientific meetings, press releases, the general media and social media.

To inform about behavioural gender and age differences in compliance with hand hygiene recommendations during the COVID-19 pandemic in Switzerland.

Observational study (24–25 June and 1–3 July 2020); validation study (4 December 2020); gender and age group estimated by observers.

Observations occurred in five supermarkets.

All customers entering the supermarkets during a 3-hour period per day (n=8245 main study) and during 1 day (n=1918 validation study).

We observed whether people disinfected their hands.

The study reveals considerable differences with respect to gender and age: For women, 58.7% (95% CI 57.3 to 60.0%) were disinfecting their hands vs 50.4% (95% CI 48.6 to 52.2%) of men. With respect to age, we identified a steep increase across age groups up to the age of 60 years and older with 35.5% (95% CI 30.7 to 40.5%) of youth (12-17 yrs) disinfecting their hands, 50.5% (95% CI 49.1 to 51.9%) of adults (18-59 yrs) vs 69.0% (95% CI 67.1 to 70.9%) of the golden age group (60-74 yrs) and 67.2% (95% CI 61.1 to 72.9%) of people older than 75 years. The validation study confirmed these differences.

The study documents substantial differences in hand hygiene compliance between gender and age groups. This should be considered in the design of protective measures to ensure clean and safe hands.

Treatment expectations are a key mechanism of placebo effects in clinical trials. In a previous study (PSY-HEART-I), preoperative expectation optimisation improved quality of life 6 months postcardiac surgery. However, barriers such as travel distance, staffing shortages and COVID-19 limited participation. This study evaluates the feasibility and acceptability of iEXPECT, a brief internet-based intervention designed to optimise expectations before heart surgery.

In this three-arm, multicentre randomised controlled trial, 160 patients undergoing elective coronary artery bypass graft surgery are randomised to: (a) standard of care (SOC); (b) SOC plus iEXPECT with phone-based guidance (iEXPECT enhanced) or (c) SOC plus iEXPECT with email-based guidance (iEXPECT limited). The intervention includes four 20 min online modules addressing surgical benefits, side effects and coping strategies. Modules are accompanied by personalised guidance provided through feedback on each module via email or telephone (three before surgery, three booster sessions at 6, 12 and 18 weeks postsurgery). Assessments occur at baseline (5–21 days before surgery), preoperatively (day before surgery), 7 days postsurgery and 6 months later. Primary feasibility outcomes include recruitment (≥1 participant/week/centre), retention (≥49% completing 6-month follow-up including biomarkers) and engagement (≥75% completing ≥1 presurgery module). Acceptability is measured by self-reported enjoyment, usefulness and impact, with acceptance defined as mean scores >3.4 (5-point Likert scale) and CSQ-I ratings. Secondary outcomes include psychological measures, inflammatory markers and heart rate variability.

Ethical approval was granted by the Ethics Committees of Philipps University Marburg (AZ 229/23 BO) and the University of Giessen (AZ 186/23). All participants provide written informed consent. Results will be shared via publications, conferences and public outreach with relevant consumer advocacy groups.

DRKS00033284.