Adrenal Insufficiency in Septic Shock - Full Text View

Sponsor:	The Methodist Hospital System
Information provided by:	The Methodist Hospital System
ClinicalTrials.gov Identifier:	NCT00842933

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: X-linked adrenoleukodystrophy

Drug Information available for: Hydrocortisone acetate Hydrocortisone Epinephrine bitartrate Epinephrine Prednisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Methylprednisolone Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate Corticosteroids

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
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental group: Experimental 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
Standard of care group: Active Comparator 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

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

Contacts

Contact: Margaret McQuiggan, MS, RD	713-441-6225	mmcquiggan@tmhs.org
Contact: Linda W Moore, CCRP	713-441-6144	lwmoore@tmhs.org

Locations

United States, Texas
The Methodist Hospital	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Laura J Moore, MD

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:	The Methodist Hospital, Department of Surgery ( Laura J Moore, MD )
Study ID Numbers:	0207-0012
Study First Received:	February 11, 2009
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00842933 History of Changes
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
Adrenal Gland Diseases
Anti-Inflammatory Agents
Prednisone
Hydrocortisone
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Infection
Hormones
Neuroprotective Agents
Pathologic Processes
Therapeutic Uses

Addison Disease
Systemic Inflammatory Response Syndrome
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Cortisol succinate
Gastrointestinal Agents
Endocrine System Diseases
Glucocorticoids
Protective Agents
Pharmacologic Actions
Inflammation
Sepsis
Shock
Autonomic Agents

ClinicalTrials.gov processed this record on February 08, 2010