Adrenal Insufficiency in Septic Shock

Stopped early · Phase 4

Conditions studied: Septic Shock, Acute Adrenal Insufficiency

In brief

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).

Key facts

Study ID

NCT00842933

Run by

The Methodist Hospital Research Institute

People needed

32

Starts

2007-05-01

Expected to finish

2011-05-01

Last updated by the study team

2011-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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