Adrenal study
Research type
Research Study
Full title
Adrenal Study-Adjunctive corticoisteroid treatment in critically ill patients with septic shock
IRAS ID
106851
Contact name
Andrew Rhodes
Sponsor organisation
The George Institute for Global Health
Eudract number
2012-003158-10
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to find out whether adult patientsadmitted to the Intensive Care Unit with septic shock who are given hydrocortisone compared to placebo (a dummy solution), will have an improved rate of survival 90 days later.Septic shock is the result of an infection, which triggers a complex response by the body (the inflammatory response) that causes a decrease in blood Pressure and subsequently one or more organ'systems to fail when blood supply to these organs is reduced. This may result in poor recovery and death. About a quarter of the people who sufferiseptic shock that is not rapidly reversed, will die. When patients are admitted to Intensive Care with sepsis and/oriseptic shock they receive a number of therapies. These include fluids given through a drip, antibiotics, drugs to boost your blood Pressure and other organ'systems. In addition to these therapies, steroids (hydrocortisone) are sometimes administered. Whetheresteroids are useful or not in the treatment of severe infections has been'studied for more than 50 years. Previous research has suggested that the use of low dose steroid may have short-term benefits in improving the circulation. However, there is no agreement amongst doctors around the world about whether treatment with or without low dose steroids improves the overall recovery and survival in patients with septic shock. This study would allow doctors to make informed decisions about whether the addition of low dose steroid therapy is better for patients with septic shock in intensive care.The study will include 3800 intensive care patients who have septic shock. Each enrolled patient will be randomised to receive either Hydrocortisone 200mg or placebo daily for 7 days as a continuous intravenous infusion while in intensive care. The patient will be followed for 90 days.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
12/EE/0368
Date of REC Opinion
11 Feb 2013
REC opinion
Further Information Favourable Opinion