Cortisol Response to Adrenocorticotrophin (ACTH) in Acute Stress (CRAAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00493389
Recruitment Status : Unknown
Verified July 2008 by University of Ottawa.
Recruitment status was:  Recruiting
First Posted : June 28, 2007
Last Update Posted : August 6, 2008
The Physicians' Services Incorporated Foundation
Ottawa Hospital Research Institute
Information provided by:
University of Ottawa

Brief Summary:

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 or disease Intervention/treatment Phase
Aortic Aneurysm, Abdominal Drug: Adrenocorticotrophic hormone Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improving The Assessment of Hypothalamic Pituitary Adrenal Function In Acute Stress
Study Start Date : July 2007
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. cortisol response [ Time Frame: within 12 hours after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00493389

Contact: Colette Favreau 613-738-8400 ext 81961
Contact: Claire Gavin, MB BCh BAO 613-738-8400 ext 81955

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
Principal Investigator: Teik-Chye Ooi, MBBS, FRCPC, University of Ottawa

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr T C Ooi, University of Ottawa Identifier: NCT00493389     History of Changes
Other Study ID Numbers: 2007255-01H
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: August 6, 2008
Last Verified: July 2008

Keywords provided by University of Ottawa:
ACTH stimulation test

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Adrenocorticotropic Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs