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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

February 11, 2009
June 28, 2011
May 2007
May 2010   (final data collection date for primary outcome measure)
The primary outcome measure for this study is the number of hours receiving steroid dosing. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00842933 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Septic Shock
  • Acute Adrenal Insufficiency
  • Drug: Corticosteroid
    Cessation of corticosteroids 24 hours after cessation of vasopressors
    Other Name: corticosteroids,prednisone,methylpredisolone,hydrocortisone
  • Drug: Corticosteroid
    Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock
    Other Name: prednisone,methylprednisolone,corticosteroid,hydrocortisone
  • Experimental: Experimental group
    Corticosteroids discontinued 24 hours after cessation of vasopressor therapy or 7 days, which ever comes first.
    Intervention: Drug: Corticosteroid
  • Active Comparator: Standard of care group
    Standard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock.
    Intervention: Drug: Corticosteroid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
May 2011
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00842933
0207-0012
Yes
Laura J Moore, MD, The Methodist Hospital, Department of Surgery
The Methodist Hospital System
Not Provided
Principal Investigator: Laura J Moore, MD The Methodist Hospital, Houston, TX
The Methodist Hospital System
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP