Comparison of Total, Salivary and Calculated Free Cortisol Levels in Patients With Severe Sepsis

October 27, 2015 updated by: ZULEYHA KARACA, TC Erciyes University

Background: The purpose of the present study was to compare serum total cortisol (STC), salivary cortisol (SaC) and calculated free cortisol (cFC) levels at the baseline and after the ACTH stimulation test, in patients with severe sepsis (SS) and to determine the suitability of SaC and cFC levels instead of STC for the diagnosis of adrenal insufficiency in patients with SS.

Methods: Thirty patients with SS (15 men, and 15 women) were compared with 16 healthy controls. Low dose ACTH stimulation test (1 µg) was performed on the first, 7th and 28th days of diagnosis of SS. STC and SaC levels were measured during ACTH stimulation test.

Study Overview

Status

Completed

Conditions

Detailed Description

More than 90% of circulating cortisol is predominantly bound to cortisol binding globulin (CBG), but also albumin. Thus, in the presence of both hypoalbuminemia and decreased CBG levels, the ratio of bound to free cortisol levels can be altered. In this situation, measurement of FC becomes more important. Direct FC measurement is time consuming and non-automated. Thus, some indirect methods to determine FC levels had been introduced. The Coolens' method may be practical to determine FC, it estimates FC levels from STC and CBG levels. In patients with CI, the synthesis of CBG and albumin is reduced leading to overestimation of adrenal insufficiency if we only use STC levels. Since some studies demonstrated that salivary cortisol (SaC) reflect free or unbound plasma cortisol levels, this method is used more often in clinical studies. STC and SaC levels at baseline and after ACTH stimulation had been used in some studies in patients with critical illness.

The aim of the present study was to compare STC, SaC and calculated free cortisol (cFC) levels at baseline and after the ACTH stimulation test in patients with SS and determine the suitability of SaC and cFC levels instead of STC for the diagnosis of adrenal insufficiency in patients with SS. And secondary aims of this study was to compare these parameters in patients with SS with healthy controls and check their effects on survival status of the patients.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38030
        • Erciyes University Medical School Department of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Thirthy patients with severe sepsis (15 men, and 15 women), and 16 (8 men and 8 women) healthy controls

Description

Inclusion Criteria:

  • Patients with severe sepsis.

Exclusion Criteria:

  • Diabetes Mellitus,
  • Pregnancy, and
  • Use of glucocorticoids of any kind.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Controls
Healthy subjects
Patients with severe sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Salivary and Calculated Free Cortisol Levels In Patients With Severe Sepsis
Time Frame: 24 months
Survival
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TST-10-2929

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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