Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Versailles
• Collaborator: Assistance Publique - Hôpitaux de Paris
• Treatments: Cortisol succinate; Fludrocortisone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

Patients admitted in intensive care units for septic shock and meeting all following criteria

• Proven infection

• Need for vasopressor to maintain systemic arterial tension above 90 mmHg

• Multiple organ dysfunction as defined by a SOFA score ³ 8.

• Need for treatment with moderate dose of corticosteroids

Exclusion Criteria:

One of the following :

• Pregnancy

• Less than 18 years old

• Moribund (i.e. expected to die on day of intensive care unit admission)