CLASSIC v2.2
Research type
Research Study
Full title
The Conservative vs. Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) Trial
IRAS ID
268321
Contact name
Marlies Ostermann
Contact email
Sponsor organisation
Rigshospitalet
Eudract number
2018-000404-42
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Danish Medicines Agency , 2018020596
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
Current international guidelines for the treatment of septic shock recommend a package of care including intravenous (IV) fluids. These guidelines recommend giving liberal volumes of IV fluid both in the first hours after septic shock diagnosis, and as a continuing therapy. However, they are based on expert opinion and not high-quality evidence. In addition, there is increasing concern that too much fluid causes fluid overload, which is harmful and makes organ failure worse.
Septic shock continues to have a high mortality level (40-50%) even in the developed world. Data from observational studies, small, single-centre trials and systematic reviews suggest benefits from restriction of IV fluids in patients with septic shock. This may increase survival in critically ill adults. However, a large clinical trial is needed to evaluate this treatment strategy.The CLASSIC trial aims to enrol a total of 1554 patients. The primary objective is to assess the benefits and harms of IV fluid restriction as compared to standard care. Patients who are eligible and enrolled into the trial will be followed up to 1-year after enrolment.
This important, high-quality trial will allow us to determine the best IV fluid administration strategy for treating septic shock in adult patients.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0604
Date of REC Opinion
18 Aug 2020
REC opinion
Further Information Favourable Opinion