Adrenal Insufficiency in Septic Shock

June 28, 2011 updated by: The Methodist Hospital Research Institute

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • corticosteroids,prednisone,methylpredisolone,hydrocortisone
Drug: Corticosteroid
Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock
Other Names:
  • prednisone,methylprednisolone,corticosteroid,hydrocortisone
Active Comparator: Standard of care group
Standard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock.
Drug: Corticosteroid
Cessation of corticosteroids 24 hours after cessation of vasopressors
Other Names:
  • corticosteroids,prednisone,methylpredisolone,hydrocortisone
Drug: Corticosteroid
Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock
Other Names:
  • prednisone,methylprednisolone,corticosteroid,hydrocortisone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Methodist Hospital Research Institute

Investigators

  • Principal Investigator: Laura J Moore, MD, The Methodist Hospital, Houston, TX

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

June 29, 2011

Last Update Submitted That Met QC Criteria

June 28, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0207-0012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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