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临床试验/CTRI/2023/09/057208
CTRI/2023/09/057208招募中4 期

VExUS(Venous Excess Ultrasound score)guided de-resuscitation versus routine fluid management in critically ill patients: Double blinded Randomized Control Study

AIIMS, Bhubaneswar1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年11月9日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
88
试验地点
1
主要终点
To compare the cumulative fluid balance on day 4 of recruitment between the intervention group & control group ( measured in ml, expressed as mean with SD)

研究概览

简要总结

Previous studies have demonstrated a dose dependent relationship between positive fluid balance and mortality and length of ICU stay. fluid accumulation increases interstitial pressure, compromises organ flow, more pronounced in encapsulated organs like liver and kidneys.

De-resuscitation of patients with fluid overload is associated with reduced mortality in critical illness. Active De-resuscitation based on clinical end points of fluid overload may be fallacious.

VExUS grading aims to achieve euvolemic state by removing excess fluid and preventing fluid overload.

This thesis will propose a standardized protocol for ultrasound guided fluid de resuscitation based on the assessment of VExUS grading.

We hypothesis that VExUS ( Venous Excess Ultrasound Score) guided de-resuscitation reduces cumulative fluid balance compared to routine fluid management in critically ill patients.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • adults >18 years admitted in SICU/CICU/HDU.
  • patients requiring aggressive fluid resuscitation in 24 hours .
  • expected ICU stay > 48 hours Inferior vena cava diameter > 2 cm at any point of ICU stay after 24 to 48 hours post admission.

排除标准

  • refusal to give consent known cases of cirrhosis with portal hypertension and IVC thrombus.
  • pregnant inadequate acoustic window prediction of ICU stay less than 48 hours in ICU/HDU.

结局指标

主要结局

To compare the cumulative fluid balance on day 4 of recruitment between the intervention group & control group ( measured in ml, expressed as mean with SD)

时间窗: day 4 of recruitment

次要结局

  • cumulative fluid balance on days 3 & 5 of recruitment(organ failure indices -p/f ratio, serum creatinine, Delta SOFA score)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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