Adrenal Insufficiency in Septic Shock

Septic Shock Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00842933
• Other study ID #: 0207-0012
• Status: Terminated
• Phase: Phase 4
• First received: February 11, 2009
• Last updated: June 28, 2011
• Start date: May 2007
• Est. completion date: May 2011

Study information

• Verified date: June 2011
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Adrenal Insufficiency
• Adrenal Insufficiency
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Corticosteroid
Cessation of corticosteroids 24 hours after cessation of vasopressors
• Corticosteroid
Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock

Locations

Country	Name	City	State
United States	The Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure for this study is the number of hours receiving steroid dosing.		7 days	No
Secondary	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	Yes