Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320099
Status:
COMPLETED
Last Update Posted:
2010-04-06
First Post:
2006-04-27
Brief Title:
Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock
Sponsor:
University of Versailles
Organization:
University of Versailles
Study Overview
Official Title:
Phase 3 Study of Corticotherapy Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COIITSS
Brief 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
A150 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 44 to 6 mmolL using continuous iv infusion of insulin up to intensive care unit discharge
A250 mg iv every 6 hours of hydrocortisone hemisuccinate for 7 days AND strict control of blood glucose levels with a target of 44 to 6 mmolL using continuous iv infusion of insulin up to intensive care unit discharge
Control arm B
B150 mg iv every 6 hours of hydrocortisone hemisuccinate 50µg through the nasogastric tube of 9 alpha fludrocortisone for 7 days
B250 mg iv every 6 hours of hydrocortisone hemisuccinatefor 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 125 that is 375 in the experimental arm versus 50 in the control arm and considering risk alpha of 005 and a risk beta of 020 254 patients per treatment arms are needed for a total of 508 patients
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
A150 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 44 to 6 mmolL using continuous iv infusion of insulin up to intensive care unit discharge
A250 mg iv every 6 hours of hydrocortisone hemisuccinate for 7 days AND strict control of blood glucose levels with a target of 44 to 6 mmolL using continuous iv infusion of insulin up to intensive care unit discharge
Control arm B
B150 mg iv every 6 hours of hydrocortisone hemisuccinate 50µg through the nasogastric tube of 9 alpha fludrocortisone for 7 days
B250 mg iv every 6 hours of hydrocortisone hemisuccinatefor 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 125 that is 375 in the experimental arm versus 50 in the control arm and considering risk alpha of 005 and a risk beta of 020 254 patients per treatment arms are needed for a total of 508 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P040421 | None | None | None |