SepTIC: Sepsis Trials in Critical Care

Phase 4

• Conditions: Sepsis; Infections and Infestations

• Registration Number: ISRCTN80791572
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-03
• Last Update Posted: 12 December 2023
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 3758

Inclusion Criteria

1. Adults (=16 years of age) admitted to ICU due to suspected sepsis and expected to stay for at least two calendar days (i.e. expected to still to be in ICU the day after tomorrow).
2. Receiving intravenous antibiotics for suspected sepsis
3. According to local clinical judgement, patient has received adequate initial early fluid resuscitation

The following inclusion are for intervention 3 only (can be after initial trial entry):
1. Intubated and mechanically ventilated and expected to continue for another 24 hours
2. Or requiring two organ support (i.e. vasopressors or renal replacement therapy)
3. An absolute lymphocyte count < 1.2 x109 /L on two consecutive calendar days at least 12 hours apart, with no values >1.2 x10^9 /L in between.

Exclusion Criteria

1. More than 24 hours since ICU admission (this does NOT apply for trial 3, GM-CSF). Note: As early intervention in sepsis is important, the aim should be to enrol eligible patients as soon after ICU admission as is practically possible.
2. Previously admitted to ICU due to sepsis on this hospital admission
3. Not expected to survive 90 days, due to pre-existing chronic (end-stage) disease
4. Not expected to survive initial resuscitation (24 hours)
5. Neutropaenia (<0.5 neutrophils x109 /L) due to chemotherapy/malignancy (but not due to sepsis)
6. A source of infection that will require a prolonged course of antibiotics, for greater than 21 days (e.g. infective endocarditis, osteomyelitis, hepatic or cerebral abscess, tuberculosis)
7. Diabetic ketoacidosis (DKA) or hyperglycaemic hyperosmolar state (HHS)
8. Within 21 days of a spontaneous subarachnoid haemorrhage
9. Diabetes Insipidus
10. Weight <40Kg

The following additional criteria relate to intervention 3 only:
1. More than 120 hours since ICU admission
2. Already receiving G-CSF or GM-CSF
3. A total white blood cell count >50 x10^9 /L
4. Allergy or previous adverse reaction to GM-CSF
5. Known to be pregnant or breastfeeding
6. Known recent (required treatment within the last 5 years) haematological malignancy
7. Solid organ or bone marrow transplantation
8. Patient weight >125kg
9. Known anaphylaxis to GM-CSF or yeast-derived products

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
90-day mortality combined with clinical state (in-hospital with organ support, in-hospital without organ support, discharged from hospital) over time

Secondary Outcome Measures

Name	Time	Method
<br> 1. Duration of mechanical ventilation, shock, renal replacement therapy up to 90 days<br> 2. Length of stay in ICU and hospital up to 90 days<br> 3. Antibiotic use (defined daily doses per 1000 occupied bed days) up to 90 days<br> 4. Infection relapse / recurrence or secondary infection requiring further antibiotic treatment up to 90 days<br> 5. Adverse events and adverse drug reactions (including antibiotic related adverse events) up to 90 days<br> 6. Health-related Quality of Life (EQ-5D-5L) and cognitive function (MoCA-Blind) at 6 months<br> 7. 1-year mortality<br>