SepTIC
Research type
Research Study
Full title
Sepsis Trials in Critical Care
IRAS ID
1005848
Contact name
Anthony Gordon
Contact email
Sponsor organisation
Imperial College London
Research summary
SepTIC is a pragmatic, open-label trial with an embedded randomised (like flipping a coin) double-blind (neither the doctor nor the participants know whether the drug or the placebo was administered), placebo-controlled, parallel group trial that will take place in up to 60 ICUs within the UK.
Participants can be included in all three trial arms (can do both 1 and 2, neither and included in 3 if eligible). There will be three randomisations. In the first two, eligible patients with sepsis will be randomised on inclusion to:
(i) a guided antibiotic therapy or normal standard of care (trial 1)
(ii) a conservative fluid treatment strategy or normal standard of care (trial 2)
(iii) In an eligible subset of more severely ill patients (~35% of the total trial population) the third randomisation will allocate patients to the addition of GM-CSF (treatment for stimulating the immune system) or placebo (trial 3), this intervention will be blinded.
Enrolment and randomisation will be performed using an online system.
There will be an internal pilot study to check the rates of patient recruitment and adherence to the study protocol. The internal pilot will run for the initial 8 months of recruitment (~350 patients) and run seamlessly into the main trial.
Patients will be followed up for the duration of their stay in ICU, to hospital discharge. Patients will be contacted for follow up and to complete a quality of life and cognitive function questionnaires 6 months from initial randomisation. Vital status will be checked via the medical records at day 90 and 1 year after randomisation.REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0339
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion