Recruiting

Cortisol Response

Sponsor:

University of Ottawa

Code:

NCT00493389

Conditions

Aortic Aneurysm, Abdominal

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Adrenocorticotrophic hormone

Study Details

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.

Conditions

Aortic Aneurysm, Abdominal

Study ID

NCT00493389

Start date

Jul, 2007

Status verified date

Jul, 2008

Completion date

Jul, 2009

Anticipated

Primary completion date

Jul, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

Adrenocorticotrophic hormone

Primary outcome measure

  • cortisol response [ Time Frame: within 12 hours after surgery ]

Central Contacts and Locations

Central contacts

Colette Favreau

613-738-8400cfavreau@ottawahospital.on.ca

Claire Gavin, MB BCh BAO

613-738-8400cgavin@ottawahospital.on.ca

Locations

The Ottawa Hospital, Riverside campus

Recruiting

Ottawa, Ontario, Canada, K1H 7W9

Principal Investigator:

Teik Chye Ooi, MBBS, FRCPC

More Information

Sponsor

University of Ottawa

Last update posted

Aug 6, 2008

Last verified

Jul, 2008

Keywords

  • ACTH stimulation test
  • cortisol
  • stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2008-08-06.