Clinical trial NCT02589431: Comparison of Total, Salivary and Calculated Free Cortisol Levels in Patients With Severe Sepsis
Official title: Comparison of Total, Salivary and Calculated Free Cortisol Levels in Patients With Severe Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Keywords: hypothalamo pituitary adrenal axis
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

* Patients with severe sepsis.

Exclusion Criteria:

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

Primary outcomes:
measure: Total Salivary and Calculated Free Cortisol Levels In Patients With Severe Sepsis
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Medical School Department of Endocrinology
Study officials:
References:
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