Adult patients with suspected sepsis receiving organ support in an intensive care unit Infections and Infestations Sepsis
Conditions
Interventions
The IMPACCT study will investigate whether it is possible to identify and stratify patients with sepsis who are at higher risk of poor outcomes and developing new infections. It is an observational s
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Admitted to an ICU for =48 hours and <120 hours (5 days) 3. Being (or has been) treated for suspected sepsis during this ICU admission: 3.1. Intravenous antibiotics to treat a known / suspected infection 3.2. Acute organ dysfunction 4. Has received organ support (any of the following): 4.1. Respiratory – any form of mechanical ventilation, non-invasive ventilation or high-flow nasal oxygen for =24h, OR 4.2. Cardiovascular – any intravenous continuous infusion of vasopressor or inotrope for =24h, OR 4.3. Renal – any form of continuous renal replacement therapy for =24 or acute and new intermittent haemodialysis with at least two episodes 5. Is expected to require ongoing care in an environment capable of providing organ support (eg and ICU or HDU) for at least one more calendar day
Exclusion criteria
Exclusion criteria: 1. Severe neutropenia (neutrophil count <0.5 x 10(9)/L) due to an underlying disease / treatment (but not sepsis) 2. Corticosteroids (intravenously or oral) of more than an equivalent dose of prednisolone 0.1mg/kg for at least 7 days within the past 30 days (not as part of sepsis management) 3. Use of therapeutic antibodies during this admission 4. Onco-haematological disease (eg, lymphoma, leukaemia, myeloma) treated within the 5 years before inclusion 5. Allogenic hematopoietic stem cell transplantation (regardless of timing) 6. Chemotherapy or immunotherapy within the last 6 months prior to inclusion date 7. Innate immune deficiency (eg, severe combined immunodeficiency) 8. Acquired immune deficiency (eg HIV or AIDS, any stage) 9. Receiving any other immunosuppressive therapy (eg anti-TNF therapies) 10. Patients with a ‘withdrawal of life-sustaining treatment’ decision, at time of inclusion 11. Moribund and not expected to survive 24 hours 12. Participation in an interventional study of immunomodulating therapy or any other unlicensed therapy 13. Pregnant or breastfeeding women 14. No social security insurance (France only) 15. Patients with restricted liberty, prisoners or under legal protection 16. Previously enrolled in IMPACCT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day all-cause mortality and new hospital acquired infection rates up to 90 days or hospital discharge (whichever comes first) will be assessed through use of medical records and contacting participants to collect their responses. (New infections will be defined as: 1. Any new infection requiring treatment more than 48 hours after stopping treatment for a previous infection AND 2. Fulfilling a definition based on the criteria used in the REAnimation Low Immune Status Markers (REALISM) study (NCT02638779) and the European Centre for Disease Prevention and Control case definition for a hospital acquired infection from the suspected anatomical site, as determined by the senior treating clinician.) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed through use of medical records and contacting participants to collect their responses: 1. 28-day all-cause mortality 2. ICU and hospital mortality rates 3. Duration of ICU stay, measured as ICU free days / number of days alive and outside of ICU, up to 28 days 4. Duration of organ support, measured as organ support free days / number of days alive without each organ support and also any organ support, up to 28 days in ICU. Organ support includes any of: extracorporeal gas exchange, invasive or non-invasive mechanical ventilation (including continuous positive pressure ventilation or non-invasive ventilation), high flow oxygen therapy (any flow =30L/min), vasopressor or inotrope support, any form of renal replacement therapy 5. Duration of Hospital stay, measured as hospital free days / number of days alive and outside of hospital, up to 90 days 6. Hospital readmission(s) as an inpatient up to day 90. We will also collect if any readmission was related to a new infection 7. Health-related quality of life at 90 days, measured using the EQ5D-5L questionnaire 8. New infections after hospital discharge up to day 90, collected via patient diaries | — |
Countries
England, France, Sweden, United Kingdom
Contacts
Public ContactRichard Cleaver
Outcome results
None listed