Adrenal Insufficiency in Septic Shock

NCT ID: NCT00842933

Last Updated: 2011-06-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-05-31

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).

Conditions

Septic Shock; Acute Adrenal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Corticosteroids discontinued 24 hours after cessation of vasopressor therapy or 7 days, which ever comes first.

Group Type: EXPERIMENTAL

Corticosteroid

Intervention Type: DRUG

Cessation of corticosteroids 24 hours after cessation of vasopressors

Standard of care group

Standard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock.

Group Type: ACTIVE_COMPARATOR

Corticosteroid

Intervention Type: DRUG

Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock

Interventions

Corticosteroid

Cessation of corticosteroids 24 hours after cessation of vasopressors

Intervention Type: DRUG

Corticosteroid

Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock

Intervention Type: DRUG

Other Intervention Names

corticosteroids,prednisone,methylpredisolone,hydrocortisone; prednisone,methylprednisolone,corticosteroid,hydrocortisone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

The Methodist Hospital, Department of Surgery

Principal Investigators

Laura J Moore, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital, Houston, TX

Locations

The Methodist Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

0207-0012

Identifier Type: -

Identifier Source: org_study_id