search
Back to results

Adrenal Insufficiency in Septic Shock

Primary Purpose

Septic Shock, Acute Adrenal Insufficiency

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Corticosteroid
Corticosteroid
Sponsored by
The Methodist Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Septic shock, Acute adrenal insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Methodist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Standard of care group

Arm Description

Corticosteroids discontinued 24 hours after cessation of vasopressor therapy or 7 days, which ever comes first.

Standard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock.

Outcomes

Primary Outcome Measures

The primary outcome measure for this study is the number of hours receiving steroid dosing.

Secondary Outcome Measures

A secondary outcome measure will be the difference between daily glucose levels, insulin requirements, and length of stay in the ICU.

Full Information

First Posted
February 11, 2009
Last Updated
June 28, 2011
Sponsor
The Methodist Hospital Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00842933
Brief Title
Adrenal Insufficiency in Septic Shock
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 Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
Unable to meet enrollment goal prior to PI transfer
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Methodist Hospital Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Acute Adrenal Insufficiency
Keywords
Septic shock, Acute adrenal insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Corticosteroids discontinued 24 hours after cessation of vasopressor therapy or 7 days, which ever comes first.
Arm Title
Standard of care group
Arm Type
Active Comparator
Arm Description
Standard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Other Intervention Name(s)
corticosteroids,prednisone,methylpredisolone,hydrocortisone
Intervention Description
Cessation of corticosteroids 24 hours after cessation of vasopressors
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Other Intervention Name(s)
prednisone,methylprednisolone,corticosteroid,hydrocortisone
Intervention Description
Administer daily for 7 days after diagnosis of acute adrenal insufficiency during septic shock
Primary Outcome Measure Information:
Title
The primary outcome measure for this study is the number of hours receiving steroid dosing.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura J Moore, MD
Organizational Affiliation
The Methodist Hospital, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Adrenal Insufficiency in Septic Shock

We'll reach out to this number within 24 hrs