Comparison of Total, Salivary and Calculated Free Cortisol Levels in Patients With Severe Sepsis
- Conditions
- Severe Sepsis
- Registration Number
- NCT02589431
- Lead Sponsor
- TC Erciyes University
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- Patients with severe sepsis.
- Diabetes Mellitus,
- Pregnancy, and
- Use of glucocorticoids of any kind.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total Salivary and Calculated Free Cortisol Levels In Patients With Severe Sepsis 24 months Survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Erciyes University Medical School Department of Endocrinology
🇹🇷Kayseri, Turkey