Long-Term Recovery and Quality of Life in Sepsis Survivors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
Sepsis (community- or hospital-acquired) diagnosed on ICU admission, defined as either: (a) a diagnosis of sepsis made by the treating clinician at ICU admission AND fulfilment of Sepsis-3 criteria; or (b) a diagnosis of sepsis made by the treating clinician at ICU admission alone, where Sepsis-3 criteria are not routinely available according to local protocol
Disqualifiers
Refusal to participate, by the patient or the legal representative
Inability to ensure follow-up (e.g. overseas residence, no fixed home address)
Sepsis acquired in the ICU
Patient admitted for palliative care
Trial population
Adult patients (18 years or older) consecutively admitted to participating ICUs with community- or hospital-acquired sepsis diagnosed by the treating clinician at ICU admission and, where locally available, meeting Sepsis-3 criteria. Participating ICUs are academic and non-academic centres in several countries. Participants represent a broad spectrum of disease severity, comorbidity and infection source. Sepsis acquired in the ICU and patients admitted for palliative care are not included. No experimental intervention is administered; all treatments follow local standard of care. Because sepsis is an emergency condition and patients frequently lack decision-making capacity at the time of ICU admission, patients are included immediately and consent is obtained from a legal representative or next of kin as soon as possible and from the patient post hoc once capacity is recovered, in accordance with articles 30 and 31 of the Swiss Human Research Act.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Care for Sepsis
Other interventionParticipants will receive standard clinical care for sepsis according to local hospital protocols. This study is purely observational: no experimental drugs, procedures, or behavioral interventions are introduced. Data will be collected prospectively on infection characteristics, timing of adequate antibiotic therapy, organ support, and rehabilitation practices during the ICU stay. Follow-up at 28 days, 3 months, and 6 months will assess patient-centered outcomes such as quality of life (EQ-5D-5L), cognitive and mental health status, and return to work. All treatments and decisions remain under the responsibility of the attending medical team.
Treatment groups
530 Participants
are divided into 1 treatment groupGroup A: Sepsis Survivors Cohort1 intervention
Trial outcomes
Primary outcomes
1
Health-related Quality of Life
Health-related quality of life measured with the EQ-5D-5L. The EQ-5D-5L index value ranges approximately from below 0 to 1, with higher values indicating better health-related quality of life. Poor quality of life is defined a priori as an index value below 0.6.
Time frame
6 months after ICU admissionSecondary outcomes
1
Health-related Quality of Life
Health-related quality of life measured with the EQ-5D-5L. The EQ-5D-5L index value ranges approximately from below 0 to 1, with higher values indicating better health-related quality of life. Poor quality of life is defined a priori as an index value below 0.6.
Time frame
7 days after ICU admission2
Health-related Quality of Life
Health-related quality of life measured with the EQ-5D-5L. The EQ-5D-5L index value ranges approximately from below 0 to 1, with higher values indicating better health-related quality of life. Poor quality of life is defined a priori as an index value below 0.6.
Time frame
28 days after ICU admission3
Health-related Quality of Life
Health-related quality of life measured with the EQ-5D-5L. The EQ-5D-5L index value ranges approximately from below 0 to 1, with higher values indicating better health-related quality of life. Poor quality of life is defined a priori as an index value below 0.6.
Time frame
3 months after ICU admission4
6-Month Mortality
All-cause mortality within 6 months of ICU admission, ascertained from medical records or during structured follow-up contact. Includes deaths during the index hospitalisation and after discharge. Cause of death is recorded, including death following withdrawal or withholding of life-sustaining treatment.
Time frame
6 months after ICU admissionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Geneva, Switzerland
Lead sponsor
University of Zurich
Collaborator
University Health Network, Toronto
Collaborator
University of Sydney
Collaborator
European Society of Intensive Care Medicine
Collaborator
Università degli Studi di Trento
Collaborator
University Hospital, Geneva
Collaborator
Source ClinicalTrials.gov