drugset / Trial / NCT00320099
Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock
Phase 3
Completed
508 enrolled
University of Versailles
Assistance Publique - Hôpitaux de Paris · collab
RandomizedFactorialTriple-blindTreatment
Summary
This study will compare, in adults with septic shock, the safety and efficacy of a combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids. In addition, this study will compare the efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone
Timeline
- Start
- 2006-01
- Primary completion
- 2009-01
- Completion
- 2009-02
Outcome
Missed primary endpoint
paper Compared with conventional insulin therapy, intensive insulin therapy did not improve in-hospital mortality among patients who were treated with hydrocortisone for septic shock. PMID 20103758 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fludrocortisone | Other / unclassified | 50 ug | Oral |
| Subject | recombinant human insulin | Protein / enzyme biologic | — | Intravenous |
| Background | Hydrocortisone | Other / unclassified | 50 mg | Intravenous |