NCT00842933

Adrenal Insufficiency in Septic Shock

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Septic Shock
• Acute Adrenal Insufficiency

Interventions

Type	Name	Description
DRUG	Corticosteroid	Cessation of corticosteroids 24 hours after cessation of vasopressors
DRUG	Corticosteroid	Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-05-01
• Completion: 2011-05-01
• First posted: 2009-02-12
• Last updated: 2011-06-29

Locations

1 site across 1 country: United States