临床试验/CTRI/2024/10/075182

CTRI/2024/10/075182尚未招募不适用

Effect of Serum Cortisol Levels on Reversal of Shock in Adults with Septic Shock- A Prospective Observational Study.

Dr DMThappaIntra Mural Research FundJIPMER1 个研究点分布在 1 个国家目标入组 180 人开始时间: 2024年10月23日最近更新: 2024年10月12日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 180
试验地点: 1
主要终点: To compare the proportion of patients develops reversal of shock between responders

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Administration of steroid therapy in patients with sepsis who have normal/high serum

cortisol level may be deleterious as the steroid can worsen the ongoing infection. This

study has been designed to study the effect of hydrocortisone on outcomes of septic

shock adults with normal/high serum cortisol.

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•1.Adults with septic shock requiring high vasopressor therapy to maintain MAP of â‰¥ 65 mmHg for more than one hour, despite adequate fluid therapy.

排除标准

•1.H/o Hypothalamic-pituitary-adrenal axis dysfunction 2.H/o Glucocorticoid/estrogen therapy
•Patients with autoimmune disorders
•Pregnancy
•H/o drug intake that influence HPA axis response.
•(Eg: ketoconazole).

结局指标

主要结局

To compare the proportion of patients develops reversal of shock between responders

时间窗: Time to reversal of shock,28 day mortality benefit.

and non-responders.

时间窗: Time to reversal of shock,28 day mortality benefit.

次要结局

To compare the 28 days mortality between critically ill septic shock adults between responders and non-responders.(To compare the length of ICU stay between critically ill septic shock adults between responders and non-responders.)

研究者

发起方

Dr DMThappaIntra Mural Research FundJIPMER

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Dr Senthilnathan M

Autonomous institution

研究点 (1)

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