Overview

Adrenal Insufficiency in Septic Shock

Status:
Terminated
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Methodist Hospital Research Institute
The Methodist Hospital System
Treatments:
Cortisol succinate
Epinephrine
Epinephryl borate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Methylprednisolone
Prednisone
Racepinephrine
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