NCT00320099

Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock

Phase 3 Study of Corticotherapy (Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone) Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 508 (actual)
• Sponsor: University of Versailles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Objectives: Comparison, in patients with septic shock, of efficacy and safety of the combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids; and of efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone Methods Study design : This is a multicenter, prospective, randomised trial on parallel groups Study treatments : Experimental arm A: A1=50 mg iv every 6 hours of hydrocortisone (hemisuccinate), 50µg through the nasogastric tube of 9 alpha fludrocortisone, for 7 days AND strict control of blood glucose levels with a target of 4,4 to 6 mmol/L using continuous iv infusion of insulin up to intensive care unit discharge. A2=50 mg iv every 6 hours of hydrocortisone (hemisuccinate) for 7 days AND strict control of blood glucose levels with a target of 4,4 to 6 mmol/L using continuous iv infusion of insulin up to intensive care unit discharge. Control arm B: B1:50 mg iv every 6 hours of hydrocortisone (hemisuccinate), 50µg through the nasogastric tube of 9 alpha fludrocortisone, for 7 days. B2:50 mg iv every 6 hours of hydrocortisone (hemisuccinate)for 7 days. Study Primary outcome : In-hospital mortality Sample size calculation : The expected in-hospital mortality rate in the control group is 50%. To detect an absolute reduction in in-hospital mortality rate of 12.5 %, that is 37.5% in the experimental arm versus 50% in the control arm, and considering risk alpha of 0,05 and a risk beta of 0,20, 254 patients per treatment arms are needed, for a total of 508 patients.

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	recombinant human insulin	intensive insulin therapy as a continuous infusion to maintain blood glucose levels between 4 and 6 mmol/l
DRUG	hydrocortisone	50 mg as iv bolus every 6 hours for 7 days
DRUG	fludrocortisone	50 µg once a day via a nasogastric tube for seven days
DRUG	Hydrocortisone	hydrocortisone 50mg q6 for 7 days

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2006-05-03
• Last updated: 2010-04-06

Locations

8 sites across 1 country: France