drugset / Trial / NCT00147004
Corticosteroid Therapy of Septic Shock - Corticus
Phase 3
Completed
500 enrolled
Hadassah Medical Organization
European Society of Intensive Care Medicine · collabInternational Sepsis Forum · collabThe Gorham Foundation · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is to determine whether steroids decrease 28-day mortality in patients with septic shock.
Timeline
- Start
- 2002-03
- Primary completion
- 2005-11
- Completion
- 2005-11
Outcome
Missed primary endpoint
paper At 28 days, there was no significant difference in mortality between patients in the two study groups who did not have a response to corticotropin PMID 18184957 ↗
paper 39.2% in the hydrocortisone group and 36.1% in the placebo group, P=0.69 PMID 18184957 ↗
Publications
- Background Annane D, Briegel J, Sprung CL. Corticosteroid insufficiency in acutely ill patients. N Engl J Med. 2003 May 22;348(21):2157-9. doi: 10.1056/NEJM200305223482123. No abstract available.
- Results Sprung CL, Annane D, Keh D, Moreno R, Singer M, Freivogel K, Weiss YG, Benbenishty J, Kalenka A, Forst H, Laterre PF, Reinhart K, Cuthbertson BH, Payen D, Briegel J; CORTICUS Study Group. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008 Jan 10;358(2):111-24. doi: 10.1056/NEJMoa071366.
- Polito A, Sonneville R, Guidoux C, Barrett L, Viltart O, Mattot V, Siami S, Lorin de la Grandmaison G, Chretien F, Singer M, Gray F, Annane D, Brouland JP, Sharshar T. Changes in CRH and ACTH synthesis during experimental and human septic shock. PLoS One. 2011;6(11):e25905. doi: 10.1371/journal.pone.0025905. Epub 2011 Nov 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydrocortisone | Other / unclassified | 50 mg | Intravenous |
Indications
No indication recorded.