Clinical Trial: Adrenal Insufficiency in Septic Shock

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 Insufficie

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 Summary:
Sponsor: The Methodist Hospital System

Current Primary Outcome: The primary outcome measure for this study is the number of hours receiving steroid dosing. [ Time Frame: 7 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: A secondary outcome measure will be the difference between daily glucose levels, insulin requirements, and length of stay in the ICU. [ Time Frame: up to 28 days ]

Original Secondary Outcome: Same as current

Information By: The Methodist Hospital System

Dates:
Date Received: February 11, 2009
Date Started: May 2007
Date Completion:
Last Updated: June 28, 2011
Last Verified: June 2011