UNCOVERNCT07863128

Long-Term Recovery and Quality of Life in Sepsis Survivors

StatusRecruiting

PhaseNot specified

SponsorUniversity of Geneva, Switzerland

Primary completionSep 1, 2027 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 1, 2026 Study First Submitted

Endpoints

Primary

Health-related Quality of Life

Timeframe: 6 months after ICU admission

Secondary (12)

Health-related Quality of Life

6-Month Mortality

Cognitive Function

Psychological Distress and Post-Traumatic Stress Symptoms

Functional Status

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Return to Work and Socioeconomic Recovery

Rehospitalization and Healthcare Utilization

Decision regret regarding the ICU stay (Decision Regret Scale)

Freedom from renal replacement therapy

Physical health-related quality of life (Short Form-12 Physical Component Summary)

Delirium during the ICU stay

Mental health-related quality of life (Short Form-12 Mental Component Summary)

Arms and interventions

Sepsis Survivors Cohort

This cohort includes adult patients (≥18 years) admitted to participating intensive care units (ICUs) with a diagnosis of sepsis according to SEPSIS-3 criteria. Participants will be followed prospectively at 28 days, 3 months, and 6 months after ICU admission to assess patient-centered outcomes including quality of life, functional recovery, cognitive status, and mental health. No experimental interventions will be administered; all treatments follow standard clinical practice. Data on infection characteristics, antibiotic timing, and ICU management will be recorded for association analyses.

Other: Care for Sepsis

Sites

1 site in 1 country

Hopitaux Universitaires de Geneve (HUG)Geneva, Switzerland

About this trial

The goal of this observational study is to learn about the long-term outcomes and recovery of adult patients admitted to the intensive care unit (ICU) with sepsis. The main questions it aims to answer are: * Which patient-related, infection-related and centre-level factors (for example type of pathogen, time to adequate antibiotic therapy, and local sepsis management practices) are associated with poor quality of life six months after ICU admission for sepsis? * How do these factors influence other patient-centred outcomes, such as mortality, psychological and cognitive recovery, functional status and return to work? This is an international, multicentre, prospective observational cohort study. It will consecutively enrol adult patients (18 years or older) admitted to participating ICUs with sepsis, diagnosed by the treating clinician at ICU admission and, where locally available, meeting Sepsis-3 criteria. Participants will: * have clinical data collected from their medical records at ICU admission, on day 7 and at ICU discharge (infection characteristics, organ support, antibiotic therapy, delirium, rehabilitation and centre organisation); * be followed at 28 days (medical record review, or telephone contact if already discharged) and contacted by telephone at 3 months and 6 months after ICU admission for structured assessment of quality of life, psychological and cognitive recovery, functional status, return to work and healthcare utilisation. The study plans to enrol 600 patients in participating ICUs across several countries, coordinated by Geneva University Hospitals (HUG). Findings will help identify modifiable factors that may improve long-term recovery and guide future interventions for sepsis survivors.

Trial details

Enrollment: 530 participants (estimated)
Started: Sep 1, 2026
Study completion: Sep 1, 2028 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee
Conditions: Sepsis, Long Term Care, Sepsis Scores, Long Term Follow-Up, Long Term Outcomes, PICS
Collaborators: University of Zurich, University Health Network, Toronto, University of Sydney, European Society of Intensive Care Medicine, Università degli Studi di Trento, University Hospital, Geneva
Official title: The UNCOVER Study: From ICU to Long-Term Recovery - An International Cohort Study on Risk Factors, Trajectories, and Quality of Life in Sepsis Survivors
First posted: Oct 7, 2026
Registry updated: Oct 7, 2026
Last verified: Oct 2026

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