Adrenal Insufficiency in Septic Shock

Phase 4

Terminated

• Conditions: Septic Shock; Acute Adrenal Insufficiency
• Interventions: Drug: Corticosteroid

• Registration Number: NCT00842933
• Lead Sponsor: The Methodist Hospital Research Institute

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

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Primary Completion: 2010-05
• Study Completion: 2011-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-28
• Last Update Posted: 2011-06-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients who are 18 years of age or older
• Patients who sign informed consent or are represented by a legally authorized representative to provide consent on behalf of the patient
• Patients with septic shock meeting the ACCM/SCCM consensus conference definitions for septic shock

Exclusion Criteria

• Patients with documented allergic or anaphylactic reactions to corticosteroids

• Patients who have received steroid therapy within 6 months of presentation

• Patients who have received steroids during their hospital admission, with the exception of a single dose of dexamethasone

• Patients who have received etomidate in the preceding 12 hours

• Patients who have had a prior adrenalectomy or a known history of adrenal disease (documented adrenal insufficiency or Cushing syndrome).

• Documented Human Immunodeficiency Virus (HIV) infection

• Pregnancy

• Allergies to adrenocorticotropic hormone (ACTH) or corticosteroids

• Administration of additional medications which may suppress the hypothalamic-pituitary axis:

  • Ketoconazole
  • Aminoglutethimide
  • Mitotane
  • Megestrol acetate
  • Suramin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Corticosteroid	Corticosteroids discontinued 24 hours after cessation of vasopressor therapy or 7 days, which ever comes first.
Standard of care group	Corticosteroid	Standard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock.

Primary Outcome Measures

Name	Time	Method
The primary outcome measure for this study is the number of hours receiving steroid dosing.	7 days

Secondary Outcome Measures

Name	Time	Method
A secondary outcome measure will be the difference between daily glucose levels, insulin requirements, and length of stay in the ICU.	up to 28 days

Trial Locations

Locations (1)

The Methodist Hospital; 🇺🇸 Houston, Texas, United States