Back to results

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

Primary Purpose

Aortic Aneurysm, Abdominal

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Adrenocorticotrophic hormone

About this trial

This is an interventional diagnostic trial for Aortic Aneurysm, Abdominal focused on measuring ACTH stimulation test, cortisol, stress

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Ottawa Hospital, Riverside campusRecruiting

Outcomes

Primary Outcome Measures

cortisol response

Secondary Outcome Measures

Full Information

NCT ID

NCT00493389

First Posted

June 26, 2007

Last Updated

August 1, 2008

Sponsor

University of Ottawa

Collaborators

The Physicians' Services Incorporated Foundation, Ottawa Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00493389

Brief Title

Cortisol Response to Adrenocorticotrophin (ACTH) in Acute Stress

Acronym

CRAAS

Official Title

Improving The Assessment of Hypothalamic Pituitary Adrenal Function In Acute Stress

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Unknown status

Study Start Date

July 2007 (undefined)

Primary Completion Date

July 2009 (Anticipated)

Study Completion Date

July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Ottawa

Collaborators

The Physicians' Services Incorporated Foundation, Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Aneurysm, Abdominal

Keywords

ACTH stimulation test, cortisol, stress

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Adrenocorticotrophic hormone

Primary Outcome Measure Information:

Title

cortisol response

Time Frame

within 12 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Colette Favreau

Phone

613-738-8400

Ext

81961

cfavreau@ottawahospital.on.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Claire Gavin, MB BCh BAO

Phone

613-738-8400

Ext

81955

cgavin@ottawahospital.on.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teik-Chye Ooi, MBBS, FRCPC,

Organizational Affiliation

University of Ottawa

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ottawa Hospital, Riverside campus

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 7W9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Teik Chye Ooi, MBBS, FRCPC

12. IPD Sharing Statement

Citations:

PubMed Identifier

8550765

Citation

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. doi: 10.1210/jcem.81.1.8550765.

Results Reference

background

PubMed Identifier

195542

Citation

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. doi: 10.1097/00000658-197707000-00005.

Results Reference

background

PubMed Identifier

1671944

Citation

Rothwell PM, Udwadia ZF, Lawler PG. Cortisol response to corticotropin and survival in septic shock. Lancet. 1991 Mar 9;337(8741):582-3. doi: 10.1016/0140-6736(91)91641-7.

Results Reference

background

PubMed Identifier

29148099

Citation

Druce I, Abujrad H, Chaker S, Meggison H, Hill A, Raymond A, Mayne J, Ooi TC. Circulating PCSK9 is lowered acutely following surgery. J Clin Lab Anal. 2018 May;32(4):e22358. doi: 10.1002/jcla.22358. Epub 2017 Nov 17.

Results Reference

derived

Learn more about this trial

Cortisol Response to Adrenocorticotrophin (ACTH) in Acute Stress

We'll reach out to this number within 24 hrs