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临床试验/CTRI/2024/07/070935
CTRI/2024/07/070935尚未招募4 期

Restrictive vs Liberal fluid management in sepsis induced hypotension

Pt JNM Medical College Raipur CG1 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2024年7月30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
364
试验地点
1
主要终点
Death from any cause before discharge home or by day 90

研究概览

简要总结

This is a prospective  randomized study to compare restrictive vs liberal fluid management in patient undergoing sepsis induce hypotension.A total number of 364 patient were enrolled in the study presenting to the CCU and will be randomized onto two two groups through sealed envelope techniques .Group A  with 182 patient receiving vasopressor as noradrenaline 5 ampoule till MAP is maintained greater than 65 mmHg Patient will be reassessed after one hour and if MAP is not maintain second vasopressor  as Vasopressin at the rate 2.4 ml/hour will be started and will be assessed till one hour. In Group B with 182 patient will receive 2 liters of bolus fluid over 1 hour followed by 2 liters over next 4 hour to maintain MAP >65 mmHg Primary outcome will be measured as Death from any cause brfore discharge or by day 90 and secndary outcomes measured will be in terms of days free from ventilator use,days free from renal replacement therapy,days free from vasopressor use, days out of CCU.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patient from 18-65 years of age with sepsis induced hypotension confirmed through SIRS diagnostic criteria with MAP less than 65 mmHg.

排除标准

  • Previous reception of greater 3000ml of IV fluid Elapse of greater than 6 hour on admission to hospital End stage renal failure Elevated jugular venous pressure Gastrointestinal bleeding in absence of fever congestive heart failure.

结局指标

主要结局

Death from any cause before discharge home or by day 90

时间窗: 90 days

次要结局

  • Days free from ventilator use(90 days)
  • day free from renal replacement therapy(Day 90)
  • Days free from vasopressor use(Day 90)
  • Day out of CCU(By day 90)

研究者

发起方
Pt JNM Medical College Raipur CG
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Anamika Tiwari

Pt. JNM medical college ,Dr. BRAM hospital raipur

研究点 (1)

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