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临床试验/CTRI/2024/07/070461
CTRI/2024/07/070461尚未招募3 期

Comparison of Venous Excess Ultrasound Grading (VEXUS) based fluid management with standard fluid management in critically ill adult burn injury patients post initial resuscitation - a randomized controlled study

All India Institute of Medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2024年7月22日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
166
试验地点
1
主要终点
Incidence of AKI at 7 days post burn resuscitation

研究概览

简要总结

Fluid resuscitation in burn injury patients is the first and most vital cog in the ICU management of these patients. Several formulae are in use to calculate the volume of fluid to be given to cover the losses, including Parkland’s formula, and Modified Brooke’s formula . However, most of these formulae were found to overpredict the volume deficit among burn injury patients, thus leading to volume overload.

Fluid creep is a common manifestation of burn injury resuscitation and has been found to present with several unwanted complications in patients(2). These include pulmonary edema, peripheral edema, decreased wound healing, compartment syndrome leading to increased ICU days and poorer outcomes(3). Another dreaded complication of fluid overload is AKI (4)Thus, monitoring adequacy of fluid resuscitation becomes essential.

Current standard methods of monitoring fluid status include urine output, lactate clearance, central venous pressure, pulse volume and blood pressure(5). The disadvantage with these methods is the subjective difference between each patient as well as between clinicians, which makes it harder to arrive at an appropriate target. Newer methods of assessing fluid status such as the Venous excess ultrasound score (VEXUS) have shown to be promising in terms of their accuracy and sensitivity in predicting fluid overload and AKI(6,7).

This randomised controlled study is aimed at comparing the incidence of AKI in critically ill burn injury patients who undergo VExUS based fluid management compared to standard fluid management, post burn resuscitation, at the end of 1 week.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Greater than or equal to 20% and less than 90% body surface area burns admitted in the ICU within 24 hours of burn injury.

排除标准

  • Pre existing kidney disease, severe portal hypertension, severe heart failure or severe lung disease Pregnant patients Patients with BMI of more than 30 Abdominal pathology interfering with the USG views Significant tricuspid or pulmonary regurgitation Patients with associated polytrauma Patients denying or withdrawing consent.

结局指标

主要结局

Incidence of AKI at 7 days post burn resuscitation

时间窗: 7 days

次要结局

  • Change in SOFA score(3 days)
  • Incidence of mortality(28 days)
  • Ventilator free days(28 days)

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

AJEET VISWANATH TP

AIIMS New Delhi

研究点 (1)

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