Clinical Trial: Corticosteroid Therapy of Septic Shock - Corticus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Corticosteroid Therapy of Septic Shock - Corticus. A Multi-National, Prospective, Double-Blind, Randomized, Placebo-Controlled Study
Brief Summary: The purpose of the study is to determine whether steroids decrease 28-day mortality in patients with septic shock.
Detailed Summary:
The use of steroids in septic shock remains controversial. The purpose of this study is to determine whether hydrocortisone decreases 28-day mortality in patients with septic shock. The primary end point will be 28-day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH). Secondary endpoints will be 28 day all cause mortality in the total group and in responders, ICU and hospital mortality, one year mortality, organ system failure reversal especially shock, and duration of ICU and total hospitalisation.
In a double-blinded fashion (randomized on a 1:1 basis), patients receive 50 mg intravenously every 6 hours for 5 days. After 5 days, treatment will be tapered with 50 mg given intravenously every 12 hours for days 6-8, then 50 mg every 24 hours for days 9-11, and then stopped.
All concomitant treatments, including antibiotics, fluids, vasopressors and ancillary therapies will be given at the discretion of the primary care physician. Evidence-based guidelines for the management of severe sepsis and septic shock by the International Sepsis Forum (Intensive Care Med 2001;27:S124-S134) are encouraged to be followed.
All serious adverse events (SAE) which occur between days 0 and 28, which are unexpected and/or considered possibly or probably related to the study medication, must be documented and reported within 24 hours to the Safety and Efficacy Monitoring Committee. Non-serious adverse events will be listed on the case report form if they are unexpected and believed to be related to the study drug during days 0 to 14.
Specific adverse events which will be monitored closely because of their relationship to corticosteroids and shock are:
- 28 day all cause mortality in the total group. [ Time Frame: 28 days ]
- 28 day all cause mortality in responders. [ Time Frame: 28 days ]
- One year mortality in nonresponders, total and responders. [ Time Frame: one year ]
- ICU and hospital mortality. [ Time Frame: one year ]
- Organ system failure reversal, especially shock. [ Time Frame: one year ]
- Duration of ICU and total hospitalisation. [ Time Frame: one year ]
- 28 day all cause mortality in the total group.
- 28 day all cause mortality in responders.
- One year mortality in nonresponders, total and responders.
- ICU and hospital mortality.
- Organ system failure reversal, especially shock.
- Duration of ICU and total hospitalisation.
Current Primary Outcome: 28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH) [ Time Frame: 28 days ]
Original Primary Outcome: 28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH)
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Hadassah Medical Organization
Dates:
Date Received: September 6, 2005
Date Started: March 2002
Date Completion:
Last Updated: April 23, 2008
Last Verified: April 2008
