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临床试验/NCT04647552
NCT04647552已完成不适用

The Effect of Hydrocortison Treatment on Angiotensin II and Angiotensin Receptors in Patients Suffering From Septic Shock: A Prospective Observational Study

Inonu University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Serum angiotensin II reseptor 2 levels

研究概览

简要总结

This study aims to evaluate the role of angiotensin II, AT1, and AT2 on catecholomine responsive and catecholomine resistant septic shock, and the effect of hydrocortisone traetment on catecholomine resistant septic shock and angiotensin II, AT1, and AT2.Angiotensin II can be used as a biomarker of vasoplegia observed in refractory septic shock unresponsive to catecholamine. In these patients; therapeutic effect of hydrocortisone on hypotension was performed by decreasing AT 2 level, AT2 should be investigated as a therapeutic target in the treatment of vasoplegia-induced hypotension and SVRI measured by minimally invasive cardiac output method suggests that it can be used as a useful parameter in the diagnosis and follow-up of vasoplegia.

详细描述

This study will be enrolled 40 patients diagnosed with septic shock according to Sepsis 3 criteria. The patients with septic shock who needed a noradrenaline infusion rate of up to 0.5µg/kg/min to maintain MAP>65 mmHg will be classified as control group (n=20) and the ones who required a noradrenaline infusion rate above 0.5µg/kg will be classified as hydrocortisone group (n=20). Blood samples will be taken for analysis of plasma angiotensin II, AT1, AT2 levels at the time of diagnosis, one hour after and on the 3rd day of the bundle and the hydrocortisone treatment. Hemodynamic parameters simultaneously obtain by continuous minimal invasive cardiac output measurement method will record.

研究设计

研究类型
Observational
观察模型
Other
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

  • septic shock patient

排除标准

  • other causes of end-stage organ failure, immunodeficiency, presence of acute mesenteric ischemia, vasospastic disease, pregnancy, other shock causes (hypovolemic, cardiogenic, neurogenic), life expectancy less than 48 hours corticosteroid use in the last 4 weeks

研究组 & 干预措施

hydrocortisone

The patients with septic shock who required a noradrenaline infusion rate above 0.5µg/kg

干预措施: Drug Steroid (Drug)

结局指标

主要结局

Serum angiotensin II reseptor 2 levels

时间窗: 0-3 days

Serum angiotensin II reseptor 2 levels

Serum angiotensin II levels

时间窗: 0-3 days

Serum angiotensin II levels

Serum angiotensin II reseptor 1 levels

时间窗: 0-3 days

Serum angiotensin II reseptor 1 levels

次要结局

  • Mortality rate(28 days)
  • SVRI(0-3 days)

研究者

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

Ayse Belin Ozer

Prof. Dr.

Inonu University

研究点 (2)

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