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Adrenal Insufficiency in Septic Shock

This study has been terminated.
(Unable to meet enrollment goal prior to PI transfer)
Sponsor:
Information provided by:
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT00842933
First received: February 11, 2009
Last updated: June 28, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Septic Shock
Acute Adrenal Insufficiency
 Drug: Corticosteroid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Shock Steroids
U.S. FDA Resources

Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • The primary outcome measure for this study is the number of hours receiving steroid dosing. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: May 2007
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842933

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

No publications provided

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
Study First Received: February 11, 2009
Last Updated: June 28, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Adrenal Insufficiency
Addison Disease
Shock
Shock, Septic
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Epinephrine
Epinephryl borate
 Methylprednisolone
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Methylprednisolone acetate
Prednisolone acetate
Hydrocortisone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Hydrocortisone-17-butyrate
Prednisolone hemisuccinate
Prednisolone phosphate
Adrenergic beta-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on June 18, 2013