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临床试验/NCT02589431
NCT02589431已完成不适用

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

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Total Salivary and Calculated Free Cortisol Levels In Patients With Severe Sepsis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with severe sepsis.

排除标准

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

结局指标

主要结局

Total Salivary and Calculated Free Cortisol Levels In Patients With Severe Sepsis

时间窗: 24 months

Survival

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ZULEYHA KARACA

Associate professor

TC Erciyes University

研究点 (1)

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