Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-01 @ 12:08 AM
Study NCT ID:
NCT00842933
Status:
TERMINATED
Last Update Posted:
2011-06-29
First Post:
2009-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adrenal Insufficiency in Septic Shock
Sponsor:
The Methodist Hospital Research Institute
Organization:
Study Overview
Official Title:
An Open-label, Prospective, Randomized, Controlled Clinical Trial of the Use of Reduced Duration Versus Standard Duration Steroid Replacement Therapy for Acute Adrenal Insufficiency in Patients With Septic Shock
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to meet enrollment goal prior to PI transfer
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized controlled trial evaluating the duration of steroid replacement therapy in patients with adrenal insufficiency and septic shock. Patients will be randomized to receive either hydrocortisone 50 mg IV every six hours for seven days (control) or hydrocortisone 50 mg IV every six hours until 24 hours after achievement of hemodynamic stability (MAP \> 65 mm Hg off of vasopressors).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: