Adrenal Insufficiency in Septic Shock

The Methodist Hospital Research Institute (TMHRI)

Status and phase: Terminated; Phase 4

Conditions: Acute Adrenal Insufficiency; Septic Shock

Treatments: Drug: Corticosteroid

Study type: Interventional

Funder types: Other

Identifiers

NCT00842933

0207-0012

Details and patient eligibility

About

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).

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Drug: Corticosteroid

Drug: Corticosteroid

Standard of care group

Active Comparator group

Description:

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

Treatment:

Drug: Corticosteroid

Drug: Corticosteroid