SepsisUNCOVERNCT07863128
Long-Term Recovery and Quality of Life in Sepsis Survivors
An observational study of Sepsis and Long Term Care, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Long Term Care, Sepsis Scores
- What is being tested?
- Care for Sepsis
- How many people
- 530 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2026to 1 Sep 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Hopitaux Universitaires de Geneve (HUG)
Geneva
Hannah Wozniak, MD, hannah.wozniak@hug.ch
Niccolo' Buetti, MD, Niccolo.buetti@hug.ch
About this study
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
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:
Read more
- 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.
Read the detailed description
Sepsis is a leading cause of death and long-term disability worldwide. Survivors often experience persistent physical, psychological and cognitive impairments, described as Post-Sepsis Syndrome in addition to Post-Intensive Care Syndrome (PICS). Despite growing recognition of these complications, the factors influencing long-term outcomes - particularly the interaction between individual characteristics, infection-related factors and centre-level practices - remain poorly understood.
UNCOVER is a prospective, international, multicentre observational cohort study designed to investigate these associations in adult ICU patients with sepsis. Geneva University Hospitals (HUG) acts as the promoter. Participating centres enrol patients consecutively; each centre targets 30 consecutive patients during a six-month enrolment period, and enrolment stops once 600 participants have been included. Additional participating ICUs in Europe, the Americas, Asia-Pacific, the Middle East and Africa will be added to this record as local ethics approvals are obtained.
Data are collected from medical records at ICU admission, on day 7 and at ICU discharge, and at follow-up 28 days, 3 months and 6 months after ICU admission. Collected variables include:
- Centre-level data (collected once per centre): hospital and ICU admission rates, availability of infectious disease consultants and clinical pharmacists, physiotherapist-to-bed ratio, nurse-to-patient and doctor-to-patient ratios, junior/senior physician ratio, proportion of mechanical ventilation beds, existence of a local sepsis bundle, family visiting policy, open/closed ICU, public/private funding, university/non-university status, admissions and patient-days during the study period.
- Admission data: socio-demographics (age, sex, nationality, ethnicity, employment, financial status), APACHE II, SOFA, comorbidities (Charlson Comorbidity Index and individual comorbidities), Clinical Frailty Scale, CAM-ICU, Glasgow Coma Scale, baseline psychiatric comorbidity, code status (full code, DNR, DNI), intubation, vasopressors.
- Day 7 data: SOFA, GCS, delirium (CAM-ICU), cultures obtained and positive cultures with pathogen, resistance and antibiogram details, antibiotic adaptation, code status, intubation, vasopressors.
- ICU discharge data: source of infection, source control measures, time to adequate antibiotic therapy, type and duration of antibiotic therapy, new sepsis episodes during the ICU stay, imaging, mechanical ventilation and its duration, tracheostomy, new organ failures, dialysis, ECMO, delirium duration and treatment, caloric intake and deficit, thiamine and steroid administration, Barthel Index at ICU discharge.
- Environmental data: ICU diary, number of physiotherapy sessions per ICU length of stay, family presence at the bedside.
Because patients with sepsis are in an emergency situation and frequently lack decision-making capacity (altered consciousness, sedation, intubation), immediate inclusion with deferred consent is used, in accordance with articles 30 and 31 of the Swiss Human Research Act: advance directives are consulted, an independent physician not involved in the research safeguards the patient's interests, proxy consent is obtained from the legal representative or next of kin as soon as possible, and consent is requested from the patient post hoc as soon as capacity is recovered.
The primary outcome is health-related quality of life measured with the EQ-5D-5L at 6 months; poor quality of life is defined a priori as an EQ-5D-5L index value below 0.6. Secondary outcomes include 6-month mortality, broader quality of life (SF-12), cognitive function (T-MoCA), post-traumatic stress symptoms (IES-R), functional status (Barthel Index, extended Barthel, IADL), frailty (Clinical Frailty Scale), return to work and socio-economic recovery, rehospitalisation and healthcare utilisation, and patient-reported decision regret and preferences regarding future ICU admission.
Pre-specified secondary analyses will examine the association between long-term patient-centred outcomes and: sepsis-related delirium during the ICU stay; duration of antibiotic therapy (7 days or less versus more than 7 days); time to adequate antibiotic therapy; hospital-acquired versus community-acquired sepsis; immunosuppression; hyperoxia exposure during the ICU stay; and clinical parameters before initiation of renal replacement therapy as predictors of renal recovery and associated long-term quality of life.
The primary analysis uses a hierarchical logistic regression model with centre as a random intercept, with predictors at centre level (country), patient level (Clinical Frailty Scale, Charlson Comorbidity Index, SOFA) and infection level (time to adequate antibiotic therapy, source control achieved). Six-month mortality is analysed with a shared-frailty Cox model with centre as the frailty term. Analyses are performed in R (version 4.3 or higher) and STATA 16.1.
No experimental intervention is administered; all treatments follow local standard of care and remain the responsibility of the attending medical team. Data are coded at source and entered into a secure REDCap registry hosted by the Swiss Society of Intensive Care Medicine (SGI/SSMI).
The study is supported by a EUR 20,000 grant from the European Society of Intensive Care Medicine (ESICM), which has no role in the design, conduct, data collection, analysis, interpretation or decision to publish.
- Conditions
- Sepsis, Long Term Care, Sepsis Scores, Long Term Follow-Up, Long Term Outcomes, PICS
- Being tested
- Care for Sepsis
- Keywords
- sepsis, long term outcomes, follow-up, sepsis sequelae, sepsis outcomes, quality of life, pics
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care for SepsisOther
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Care for Sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after ICU admission
Secondary outcomes (20)
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.
Measured: 7 days after ICU admission
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.
Measured: 28 days after ICU admission
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.
Measured: 3 months after ICU admission
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.
Measured: 6 months after ICU admission
Cognitive Function
Cognitive function assessed by the Telephone Montreal Cognitive Assessment (T-MoCA). Lower scores indicate greater cognitive impairment. Cognitive impairment is defined a priori as a T-MoCA score below 12.
Measured: 6 months after ICU admission
Cognitive Function
Cognitive function assessed by the Telephone Montreal Cognitive Assessment (T-MoCA). Lower scores indicate greater cognitive impairment. Cognitive impairment is defined a priori as a T-MoCA score below 12.
Measured: 3 months after ICU admission
Psychological Distress and Post-Traumatic Stress Symptoms
Post-traumatic stress symptoms assessed with the Impact of Event Scale-Revised (IES-R, range 0 to 88). Analysed as a continuous score; clinically significant post-traumatic stress is defined a priori as a score above 33.
Measured: 6 months after ICU admission
Psychological Distress and Post-Traumatic Stress Symptoms
Post-traumatic stress symptoms assessed with the Impact of Event Scale-Revised (IES-R, range 0 to 88). Analysed as a continuous score; clinically significant post-traumatic stress is defined a priori as a score above 33.
Measured: 3 months after ICU admission
Functional Status
Barthel Index recorded at ICU discharge and at day 28, from medical record review or telephone contact if the patient has already been discharged. Lower scores indicate greater functional dependency.
Measured: 3 months after ICU admission
Functional Status
Barthel Index recorded at ICU discharge and at day 28, from medical record review or telephone contact if the patient has already been discharged. Lower scores indicate greater functional dependency.
Measured: 6 months after ICU admission
Return to Work and Socioeconomic Recovery
Self-reported return to paid employment, whether family caregivers resumed work, whether the participant receives nursing support at home, and financial status (no difficulty, new difficulty, or same as before sepsis), recorded during structured telephone follow-up.
Measured: 6 months after ICU admission
Return to Work and Socioeconomic Recovery
Self-reported return to paid employment, whether family caregivers resumed work, whether the participant receives nursing support at home, and financial status (no difficulty, new difficulty, or same as before sepsis), recorded during structured telephone follow-up.
Measured: 3 months after ICU admission
Rehospitalization and Healthcare Utilization
Cumulative number and causes of rehospitalisations and outpatient consultations, collected through medical record review and participant self-report during the follow-up interview.
Measured: 6 months after ICU admission
Decision regret regarding the ICU stay (Decision Regret Scale)
Regret regarding the ICU stay assessed with the five-item Decision Regret Scale, administered during structured telephone follow-up. Item responses are summed and linearly transformed to a total score ranging from 0 (no regret) to 100 (maximum regret); higher scores indicate greater regret. The continuous score is the registered outcome measure. For dichotomised analyses, moderate-to-strong regret is defined a priori as a score above 25, with a score of 0 indicating no regret and 1 to 25 indicating mild regret. Where a participating centre administers a validated language version with a different reported threshold, that threshold will be applied in pre-specified sensitivity analyses.
Measured: 6 months after ICU admission
Freedom from renal replacement therapy
Percentage of participants who are alive and free from renal replacement therapy 6 months after ICU admission, among those who received renal replacement therapy for sepsis-associated acute kidney injury during the ICU stay. Freedom from renal replacement therapy is defined as no renal replacement therapy of any modality during the 30 days preceding the 6-month assessment, ascertained from medical record review and structured telephone follow-up. Participants who died before the 6-month assessment are counted as not having recovered renal function.
Measured: 6 months after ICU admission
Physical health-related quality of life (Short Form-12 Physical Component Summary)
Physical Component Summary (PCS) score of the Short Form-12 Health Survey (SF-12), administered during structured telephone follow-up. The PCS is a norm-based score calibrated to a general-population mean of 50 and standard deviation of 10, ranging from 0 (worst physical health) to 100 (best physical health); higher scores indicate better physical health. The continuous score is the registered outcome measure. For dichotomised analyses, impaired physical health is defined a priori as a PCS score more than one standard deviation below the general-population norm (score below 40); where a country-specific general-population norm is available for a participating centre, that norm will be used in pre-specified sensitivity analyses.
Measured: 3 months after ICU admission
Delirium during the ICU stay
Presence of delirium assessed with the CAM-ICU during the ICU stay, with duration of delirium and treatments administered.
Measured: 6 months after ICU admission
Mental health-related quality of life (Short Form-12 Mental Component Summary)
Mental Component Summary (MCS) score of the Short Form-12 Health Survey (SF-12), administered during structured telephone follow-up. The MCS is a norm-based score calibrated to a general-population mean of 50 and standard deviation of 10, ranging from 0 (worst mental health) to 100 (best mental health); higher scores indicate better mental health. The continuous score is the registered outcome measure. For dichotomised analyses, impaired mental health is defined a priori as an MCS score more than one standard deviation below the general-population norm (score below 40); where a country-specific general-population norm is available for a participating centre, that norm will be used in pre-specified sensitivity analyses.
Measured: 3 months after ICU admission
Mental health-related quality of life (Short Form-12 Mental Component Summary)
Mental Component Summary (MCS) score of the Short Form-12 Health Survey (SF-12), administered during structured telephone follow-up. The MCS is a norm-based score calibrated to a general-population mean of 50 and standard deviation of 10, ranging from 0 (worst mental health) to 100 (best mental health); higher scores indicate better mental health. The continuous score is the registered outcome measure. For dichotomised analyses, impaired mental health is defined a priori as an MCS score more than one standard deviation below the general-population norm (score below 40); where a country-specific general-population norm is available for a participating centre, that norm will be used in pre-specified sensitivity analyses.
Measured: 6 months after ICU admission
Physical health-related quality of life (Short Form-12 Physical Component Summary)
Physical Component Summary (PCS) score of the Short Form-12 Health Survey (SF-12), administered during structured telephone follow-up. The PCS is a norm-based score calibrated to a general-population mean of 50 and standard deviation of 10, ranging from 0 (worst physical health) to 100 (best physical health); higher scores indicate better physical health. The continuous score is the registered outcome measure. For dichotomised analyses, impaired physical health is defined a priori as a PCS score more than one standard deviation below the general-population norm (score below 40); where a country-specific general-population norm is available for a participating centre, that norm will be used in pre-specified sensitivity analyses.
Measured: 6 months after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Sep 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 530 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Hannah Wozniak, University of Geneva, Switzerland
- Investigators
- Niccolo' Buetti, MD, Study chair, Geneva University Hospitals (HUG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863128
- Sponsor's protocol ID
- UNCOVER
- Acronym
- UNCOVER
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07863128
- Acronym / sponsor ID
- UNCOVER / UNCOVER
- Conditions
- Sepsis, Long Term Care, Sepsis Scores, Long Term Follow-Up, Long Term Outcomes, PICS
- Keywords
- sepsis, long term outcomes, follow-up, sepsis sequelae, sepsis outcomes, quality of life, pics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- 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
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sepsis is a leading cause of death and long-term disability worldwide. Survivors often experience persistent physical, psychological and cognitive impairments, described as Post-Sepsis Syndrome in addition to Post-Intensive Care Syndrome (PICS). Despite growing recognition of these complications, the factors influencing long-term outcomes - particularly the interaction between individual characteristics, infection-related factors and centre-level practices - remain poorly understood.
UNCOVER is a prospective, international, multicentre observational cohort study designed to investigate these associations in adult ICU patients with sepsis. Geneva University Hospitals (HUG) acts as the promoter. Participating centres enrol patients consecutively; each centre targets 30 consecutive patients during a six-month enrolment period, and enrolment stops once 600 participants have been included. Additional participating ICUs in Europe, the Americas, Asia-Pacific, the Middle East and Africa will be added to this record as local ethics approvals are obtained.
Data are collected from medical records at ICU admission, on day 7 and at ICU discharge, and at follow-up 28 days, 3 months and 6 months after ICU admission. Collected variables include:
- Centre-level data (collected once per centre): hospital and ICU admission rates, availability of infectious disease consultants and clinical pharmacists, physiotherapist-to-bed ratio, nurse-to-patient and doctor-to-patient ratios, junior/senior physician ratio, proportion of mechanical ventilation beds, existence of a local sepsis bundle, family visiting policy, open/closed ICU, public/private funding, university/non-university status, admissions and patient-days during the study period.
- Admission data: socio-demographics (age, sex, nationality, ethnicity, employment, financial status), APACHE II, SOFA, comorbidities (Charlson Comorbidity Index and individual comorbidities), Clinical Frailty Scale, CAM-ICU, Glasgow Coma Scale, baseline psychiatric comorbidity, code status (full code, DNR, DNI), intubation, vasopressors.
- Day 7 data: SOFA, GCS, delirium (CAM-ICU), cultures obtained and positive cultures with pathogen, resistance and antibiogram details, antibiotic adaptation, code status, intubation, vasopressors.
- ICU discharge data: source of infection, source control measures, time to adequate antibiotic therapy, type and duration of antibiotic therapy, new sepsis episodes during the ICU stay, imaging, mechanical ventilation and its duration, tracheostomy, new organ failures, dialysis, ECMO, delirium duration and treatment, caloric intake and deficit, thiamine and steroid administration, Barthel Index at ICU discharge.
- Environmental data: ICU diary, number of physiotherapy sessions per ICU length of stay, family presence at the bedside.
Because patients with sepsis are in an emergency situation and frequently lack decision-making capacity (altered consciousness, sedation, intubation), immediate inclusion with deferred consent is used, in accordance with articles 30 and 31 of the Swiss Human Research Act: advance directives are consulted, an independent physician not involved in the research safeguards the patient's interests, proxy consent is obtained from the legal representative or next of kin as soon as possible, and consent is requested from the patient post hoc as soon as capacity is recovered.
The primary outcome is health-related quality of life measured with the EQ-5D-5L at 6 months; poor quality of life is defined a priori as an EQ-5D-5L index value below 0.6. Secondary outcomes include 6-month mortality, broader quality of life (SF-12), cognitive function (T-MoCA), post-traumatic stress symptoms (IES-R), functional status (Barthel Index, extended Barthel, IADL), frailty (Clinical Frailty Scale), return to work and socio-economic recovery, rehospitalisation and healthcare utilisation, and patient-reported decision regret and preferences regarding future ICU admission.
Pre-specified secondary analyses will examine the association between long-term patient-centred outcomes and: sepsis-related delirium during the ICU stay; duration of antibiotic therapy (7 days or less versus more than 7 days); time to adequate antibiotic therapy; hospital-acquired versus community-acquired sepsis; immunosuppression; hyperoxia exposure during the ICU stay; and clinical parameters before initiation of renal replacement therapy as predictors of renal recovery and associated long-term quality of life.
The primary analysis uses a hierarchical logistic regression model with centre as a random intercept, with predictors at centre level (country), patient level (Clinical Frailty Scale, Charlson Comorbidity Index, SOFA) and infection level (time to adequate antibiotic therapy, source control achieved). Six-month mortality is analysed with a shared-frailty Cox model with centre as the frailty term. Analyses are performed in R (version 4.3 or higher) and STATA 16.1.
No experimental intervention is administered; all treatments follow local standard of care and remain the responsibility of the attending medical team. Data are coded at source and entered into a secure REDCap registry hosted by the Swiss Society of Intensive Care Medicine (SGI/SSMI).
The study is supported by a EUR 20,000 grant from the European Society of Intensive Care Medicine (ESICM), which has no role in the design, conduct, data collection, analysis, interpretation or decision to publish.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis Survivors Cohort | – | Other: Care for SepsisThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care for SepsisParticipants 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. | Other | Sepsis Survivors Cohort |
Primary outcome
Health-related Quality of Life
Time frame: 6 months after ICU admission
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.
20 secondary outcomes
Health-related Quality of Life
Time frame: 7 days after ICU admission
Health-related Quality of Life
Time frame: 28 days after ICU admission
Health-related Quality of Life
Time frame: 3 months after ICU admission
6-Month Mortality
Time frame: 6 months after ICU admission
Cognitive Function
Time frame: 6 months after ICU admission
Cognitive Function
Time frame: 3 months after ICU admission
Psychological Distress and Post-Traumatic Stress Symptoms
Time frame: 6 months after ICU admission
Psychological Distress and Post-Traumatic Stress Symptoms
Time frame: 3 months after ICU admission
Functional Status
Time frame: 3 months after ICU admission
Functional Status
Time frame: 6 months after ICU admission
Return to Work and Socioeconomic Recovery
Time frame: 6 months after ICU admission
Return to Work and Socioeconomic Recovery
Time frame: 3 months after ICU admission
Rehospitalization and Healthcare Utilization
Time frame: 6 months after ICU admission
Decision regret regarding the ICU stay (Decision Regret Scale)
Time frame: 6 months after ICU admission
Freedom from renal replacement therapy
Time frame: 6 months after ICU admission
Physical health-related quality of life (Short Form-12 Physical Component Summary)
Time frame: 3 months after ICU admission
Delirium during the ICU stay
Time frame: 6 months after ICU admission
Mental health-related quality of life (Short Form-12 Mental Component Summary)
Time frame: 3 months after ICU admission
Mental health-related quality of life (Short Form-12 Mental Component Summary)
Time frame: 6 months after ICU admission
Physical health-related quality of life (Short Form-12 Physical Component Summary)
Time frame: 6 months after ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Niccolo' Buetti, MD study chair
Geneva University Hospitals (HUG)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Long Term Care, run by University of Geneva, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Wozniak, MD (+41 (7)95530291, hannah.wozniak@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (time frame: 6 months after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.