Cortisol Response to Adrenocorticotrophin (ACTH) in Acute Stress
Information source: University of Ottawa
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aortic Aneurysm, Abdominal
Intervention: Adrenocorticotrophic hormone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Ottawa Official(s) and/or principal investigator(s): Teik-Chye Ooi, MBBS, FRCPC,, Principal Investigator, Affiliation: University of Ottawa
Overall contact: Colette Favreau, Phone: 613-738-8400, Ext: 81961, Email: cfavreau@ottawahospital.on.ca
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.
Clinical Details
Official title: Improving The Assessment of Hypothalamic Pituitary Adrenal Function In Acute Stress
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: cortisol response
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
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Colette Favreau, Phone: 613-738-8400, Ext: 81961, Email: cfavreau@ottawahospital.on.ca
The Ottawa Hospital, Riverside campus, Ottawa, Ontario K1H 7W9, Canada; Recruiting Teik Chye Ooi, MBBS, FRCPC, Principal Investigator
Additional Information
Related 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.
Starting date: July 2007
Last updated: August 1, 2008
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