ADjunctive coRticosteroid trEatment iN criticAlly ilL Patients With Septic Shock
Status:
Completed
Trial end date:
2017-11-20
Target enrollment:
Participant gender:
Summary
The purpose of this study is to find out whether adult patients admitted 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 suffer septic shock that is not
rapidly reversed, will die.
When patients are admitted to Intensive Care with sepsis and/or septic 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. Whether
steroids 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
shortterm 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. If the patient is discharged prior to 90 days a telephone call will be made for
the followup information. At six months the patient will be contacted again for completion of
a quality of life questionnaire.
Phase:
Phase 4
Details
Lead Sponsor:
The George Institute
Collaborators:
Australian and New Zealand Intensive Care Society Clinical Trials Group National Health and Medical Research Council, Australia