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临床试验/CTRI/2024/06/068535
CTRI/2024/06/068535尚未招募4 期

COMPARATIVE STUDY OF NORADRENALINE ALONE VERSUS NORADRENALINE AND TERLIPRESSIN FOR MANAGEMENT OF SEPTIC SHOCK IN ICU: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY.

TEZPUR MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年6月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Dose of noradrenaline require to achieve target mean arterial pressure of 65-70 mmHg after 12 hours of starting infusion.

研究概览

简要总结

Sepsis is defined as a life threatening organ dysfunction caused by a dysregulated host response to infection. Vasoactive drugs are important to maintain the stability of hemodynamics and ensure the perfusion of major organs. Noradrenaline is the first line of drug for septic shock.The aim of the study is to  compare noradrenaline alone versus noradrenaline and terlipressin combined in the management of septic shock in ICU. The study will be conducted in the central intensive care unit, Tezpur Medical College and Hospital for a period of 1 year which is a prospective randomized controlled study. The study will include patient age more than 18 years with septic shock presenting with mean arterial pressure <65 mmHg despite appropriate volume resuscitation. The participants will be recruited and randomized by using computer created random number technique using the allocation ratio 1:1. Group 1 patients will received terlipressin 0.01 mcg/kg/min ( fixed dose infusion) and infusion noradrenaline 0.01-3 mcg/kg/min and group 2 patients will received infusion noradrenaline 0.01-3 mcg/kg/min. Primary outcome is to measure the dose of noradrenaline require to achieve target mean arterial pressure of 65-70 mmHg after 12 hours of infusion. And secondary outcomes are to measure the length of ICU stayed, duration of vasopressor requirement, changes in the serum lactate level, urine output in ml/hour, changes in qSOFA in 12 hours post-initiation of infusion and incidence of serious adverse events like digital ischaemia, cardiac arrythmias, diarrhoea and upper GI bleed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patient with septic shock presenting with mean arterial pressure less than 65 mmHg despite appropriate volume resuscitation.

排除标准

  • Patient age less than 18 years, presence of severe comorbid conditions, requirement of any other vasopressor, need of more than 3 mcg/kg/minute of noradrenaline infusion to achieve the target mean arterial pressure.

结局指标

主要结局

Dose of noradrenaline require to achieve target mean arterial pressure of 65-70 mmHg after 12 hours of starting infusion.

时间窗: Dose of noradrenaline require to achieve target mean arterial pressure of 65-70 mmHg after 12 hours of starting infusion.

次要结局

  • Length of ICU stay(Duration of vasopressor requirement)

研究者

发起方
TEZPUR MEDICAL COLLEGE AND HOSPITAL
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR ALTAFUDDIN AHMED

TEZPUR MEDICAL COLLEGE AND HOSPITAL

研究点 (1)

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