Cortisol Response to Adrenocorticotrophin (ACTH) in Acute Stress - Full Text View

Sponsor:	University of Ottawa
Collaborators:	The Physicians' Services Incorporated Foundation Ottawa Hospital Research Institute
Information provided by:	University of Ottawa
ClinicalTrials.gov Identifier:	NCT00493389

Purpose

Cortisol deficiency is diagnosed by the adrenocorticotrophin (ACTH) stimulation test. This test measures cortisol levels in the blood before and after giving an injection of ACTH. Currently, the results of this test can only be reliably interpreted when it is carried out on people in non-stressful situations. Frequently the test is carried out in hospitalized patients in stressful situations, giving results that are hard to interpret.

Our study is to first do this test in a non-stressful situation, followed by a repeat test in a stressful situation, to compare the results and create a set of guidelines for interpreting the test when it is carried out in stressful situations.

Condition	Intervention
Aortic Aneurysm, Abdominal	Drug: Adrenocorticotrophic hormone

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Improving The Assessment of Hypothalamic Pituitary Adrenal Function In Acute Stress

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate Corticotropin

U.S. FDA Resources

Further study details as provided by University of Ottawa:

Primary Outcome Measures:

cortisol response [ Time Frame: within 12 hours after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Detailed Description:

This study proposes to provide the reference range of cortisol results when the ACTH stimulation test is done under stressful conditions. This important information is currently not available in the literature. To achieve this, we will perform the ACTH stimulation test in a cohort of patients who are booked for elective surgery. By choosing elective surgery patients, we afford ourselves the opportunity of performing the test once before surgery. The test is then repeated within 12 hours of surgery. The first test will be done on an out-patient basis under usual conditions (minimal stress) while the second will be done under intense physical stress. The 2 sets of results will be compared and the effect of stress on test results will be determined. For the sake of uniformity, we have chosen patients who are booked to undergo repair of an abdominal aortic aneurysm (AAA) as our study cohort.

The ACTH stimulation is an important test that suffers from limitations resulting from lack of clear guidelines for the interpretation of results done under stressful conditions. This study will thus improve the usefulness of an important tool in the evaluation of the hypothalamic-pituitary-adrenal axis in stressed patients.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females aged 40 to 80 years, who are booked for elective open repair of abdominal aortic aneurysm at The Ottawa Hospital Civic campus

Exclusion Criteria:

Inability to provide informed consent
Pre-operative signs and symptoms of hypofunction of the HPA axis
Pre-operative AST results that indicate HPA failure, necessitating perioperative hydrocortisone coverage (Cortisol level post-ACTH < 500 nmol/L)
Presence of multiple co-morbidities such as poorly controlled diabetes, dialysis-dependant renal failure, hepatic failure
Presence of hypoalbuminaemia < 35 g/L
Untreated endocrine disorders such as hypothyroidism, hypopituitarism, hypogonadism detected by pre-operative measurement of TSH, FT4, LH, FSH and free testosterone. Such patients will receive any appropriate treatment prior to surgery. Once treated, participation in the study will be offered again and results analysed separately
Being on drugs (a) that affect cortisol synthesis (eg. Ketoconazole, etomidate) or protein binding (eg. Estrogens), (b) any form of glucocorticoid which would inhibit CRH and ACTH secretion.
Use of herbal or anabolic supplements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493389

Contacts

Contact: Colette Favreau	613-738-8400 ext 81961	cfavreau@ottawahospital.on.ca
Contact: Claire Gavin, MB BCh BAO	613-738-8400 ext 81955	cgavin@ottawahospital.on.ca

Locations

Canada, Ontario
The Ottawa Hospital, Riverside campus	Recruiting
Ottawa, Ontario, Canada, K1H 7W9
Principal Investigator: Teik Chye Ooi, MBBS, FRCPC

Sponsors and Collaborators

University of Ottawa

The Physicians' Services Incorporated Foundation

Ottawa Hospital Research Institute

Investigators

Principal Investigator:

Teik-Chye Ooi, MBBS, FRCPC,

University of Ottawa

More Information

Publications:

Streeten DH, Anderson GH Jr, Bonaventura MM. The potential for serious consequences from misinterpreting normal responses to the rapid adrenocorticotropin test. J Clin Endocrinol Metab. 1996 Jan;81(1):285-90.

Sibbald WJ, Short A, Cohen MP, Wilson RF. Variations in adrenocortical responsiveness during severe bacterial infections. Unrecognized adrenocortical insufficiency in severe bacterial infections. Ann Surg. 1977 Jul;186(1):29-33.

Rothwell PM, Udwadia ZF, Lawler PG. Cortisol response to corticotropin and survival in septic shock. Lancet. 1991 Mar 9;337(8741):582-3.

Responsible Party:	Dr T C Ooi, University of Ottawa
ClinicalTrials.gov Identifier:	NCT00493389 History of Changes
Other Study ID Numbers:	2007255-01H
Study First Received:	June 26, 2007
Last Updated:	August 1, 2008
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Ottawa:

ACTH stimulation test
cortisol
stress

Additional relevant MeSH terms:

Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Adrenocorticotropic Hormone
Hormones
Beta-Endorphin

Hydrocortisone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012