Status:
TERMINATED
Adrenal Insufficiency in Septic Shock
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
Septic Shock
Acute Adrenal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00842933
Start Date
May 1 2007
End Date
May 1 2011
Last Update
June 29 2011
Active Locations (1)
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1
The Methodist Hospital
Houston, Texas, United States, 77030