Evaluating a new test of the immune system to better understand recovery from a severe reaction to an infection (sepsis)
- Conditions
- Adult patients with suspected sepsis receiving organ support in an intensive care unitInfections and InfestationsSepsis
- Registration Number
- ISRCTN11364482
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 600
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>(New infections will be defined as: <br>1. Any new infection requiring treatment more than 48 hours after stopping treatment for a previous infection AND<br>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 Outcome Measures
Name Time Method