临床试验/CTRI/2024/08/071911

CTRI/2024/08/071911尚未招募Phase 3 4

A Double blinded Randomized study to compare the efficacy of Vasopressin versus Norepinephrine determined by improvement in markers of tissue perfusion within first sixty minutes in neonates with fluid refractory septic shock.

Bharati Vidyapeeth Deemed University Medical College Pune1 个研究点分布在 1 个国家目标入组 146 人开始时间: 2024年8月13日最近更新: 2024年8月1日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方
入组人数: 146
试验地点: 1
主要终点: Improvement in markers of tissue perfusion

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

This study will help compare the efficacy of Vasopressin and Norepinephrine in fluid refractory septic shock in neonates in terms of improvement in markers of tissue perfusion.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 0.00 Day(s) 至 28.00 Day(s)（—）
性别: All

入选标准

•All neonates admitted to NICU with signs of septic shock.

排除标准

•Septic neonates with poor ventricular contractility on functional ECHO.
•Pre-existing heart disease (clinically or echocardiographic diagnosed) or arrhythmias.
•Out born neonates with ongoing sepsis, and on inotropic/vasopressor support prior to enrolment
•Congenital life-threatening anomalies.

结局指标

主要结局

Improvement in markers of tissue perfusion

时间窗: Sixty minutes of starting drug

次要结局

To evaluate duration of using vasopressor(7 days)
To evaluate safety profile of Vasopressin(7 days)
To evaluate the need for additional vasopressor(7 days)
To compare complications of both the drugs(at discharge of the baby)
Mortality(at death of the baby, if the baby expires or at the discharge of the baby)
Length of stay(at discharge of the baby)

研究者

发起方

Bharati Vidyapeeth Deemed University Medical College Pune

申办方类型

Private medical college

责任方

Principal Investigator

主要研究者

Anurag Sanjeev Pikle

Bharati Vidyapeeth Deemed University Medical College, Pune

研究点 (1)

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