Adrenal Insufficiency in Septic Shock

An Open-label, Prospective, Randomized, Controlled Clinical Trial of the Use of Reduced Duration Versus Standard Duration Steroid Replacement Therapy for Acute Adrenal Insufficiency in Patients With Septic Shock

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00842933

Enrollment

Registered

2009-02-12

Start date

2007-05-31

Completion date

2011-05-31

Last updated

2011-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Adrenal Insufficiency, Septic Shock

Keywords

Septic shock, Acute adrenal insufficiency

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).

Interventions

DRUGCorticosteroid

Cessation of corticosteroids 24 hours after cessation of vasopressors

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The primary outcome measure for this study is the number of hours receiving steroid dosing.	7 days

Secondary

Measure	Time frame
A secondary outcome measure will be the difference between daily glucose levels, insulin requirements, and length of stay in the ICU.	up to 28 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026