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Adrenal Insufficiency in Septic Shock

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ClinicalTrials.gov Identifier: NCT00842933
Recruitment Status : Terminated (Unable to meet enrollment goal prior to PI transfer)
First Posted : February 12, 2009
Last Update Posted : June 29, 2011
Information provided by:
The Methodist Hospital System

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).

Condition or disease Intervention/treatment Phase
Septic Shock Acute Adrenal Insufficiency Drug: Corticosteroid Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2007
Primary Completion Date : May 2010
Study Completion Date : May 2011

Arm Intervention/treatment
Experimental: Experimental group
Corticosteroids discontinued 24 hours after cessation of vasopressor therapy or 7 days, which ever comes first.
Drug: Corticosteroid
Cessation of corticosteroids 24 hours after cessation of vasopressors
Other Name: corticosteroids,prednisone,methylpredisolone,hydrocortisone
Active Comparator: Standard of care group
Standard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock.
Drug: Corticosteroid
Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock
Other Name: prednisone,methylprednisolone,corticosteroid,hydrocortisone

Primary Outcome Measures :
  1. The primary outcome measure for this study is the number of hours receiving steroid dosing. [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. A secondary outcome measure will be the difference between daily glucose levels, insulin requirements, and length of stay in the ICU. [ Time Frame: up to 28 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842933

United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Principal Investigator: Laura J Moore, MD The Methodist Hospital, Houston, TX

Responsible Party: Laura J Moore, MD, The Methodist Hospital, Department of Surgery
ClinicalTrials.gov Identifier: NCT00842933     History of Changes
Other Study ID Numbers: 0207-0012
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: June 29, 2011
Last Verified: June 2011

Keywords provided by The Methodist Hospital System:
Septic shock
Acute adrenal insufficiency

Additional relevant MeSH terms:
Shock, Septic
Adrenal Insufficiency
Pathologic Processes
Systemic Inflammatory Response Syndrome
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Epinephryl borate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents