跳至主要内容
临床试验/CTRI/2025/10/096269
CTRI/2025/10/096269尚未招募不适用

Development of a Novel Fluid Tolerance index in patients undergoing Emergency Laparotomy

AIIMS, New Delhi1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2025年10月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
165
试验地点
1
主要终点
Development of a composite index of cumulative fluid balance, estimated colloidal oncotic pressure, and markers of inflammation/endothelial damage to predict the major post operative complication( Clavein Dindo Grade IV-V)

研究概览

简要总结

Fluid therapy is the cornerstone of patient management in the perioperative setting. While a liberal approach to fluid therapy was used in the past to prevent hypovolemia and improve organ perfusion , it was shown that tissue inflammation and consequent extravascular leak led to fluid accumulation in the third space, contributing to perioperative complications . As evidence emerged that a positive fluid balance was associated with increased risk of adverse surgical outcomes as well as organ dysfunction, such as acute lung injury , acute kidney injury and prolonged duration of mechanical ventilation and ICU stay, restricted or goal-directed fluid therapy (zero-balance approach) began to replace the conventional approach to fluid management. Whenever intravenous fluid therapy is administered for any reason, only a portion of the total fluid received stays inside the intravascular compartment; the rest extravasates into the capillary interstitial space Capillary fluid leak is determined by net filtration pressure and integrity of capillary endothelium and glycocalyx, the latter one cannot be quantified It arises the need of development of a composite index comprising of colloidal oncotic pressure and markers of inflammation which will module the effect of cumulative fluid balance in post-surgical patients

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Undergoing emergency abdominal Surgery 2)Duration of surgery at least 2 hours.

排除标准

  • Refusal to participate 2) CKD Stage IV or V 3) Pregnancy 4) Moribund patients with expected survival less than 48 hours.

结局指标

主要结局

Development of a composite index of cumulative fluid balance, estimated colloidal oncotic pressure, and markers of inflammation/endothelial damage to predict the major post operative complication( Clavein Dindo Grade IV-V)

时间窗: 72 hours

次要结局

  • Association between Fluid tolerance index and hospital mortality(72 hours)
  • Association of fluid tolerance index and hospital stay(72 hours)
  • Association between individual components and post operative clinical outcome(72 hours)

研究者

发起方
AIIMS, New Delhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Kritikha R

AIIMS New Delhi

研究点 (1)

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