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临床试验/CTRI/2025/02/080614
CTRI/2025/02/080614尚未招募4 期

Comparison of Terlipressin vs Noradrenaline Through Assessment of Respiratory Parameters, Lung Ultrasound Scores, and RALES Score in Patients With Hepatorenal Syndrome – A Comparative Randomized Controlled Study

AIG Hospitals1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
AIG Hospitals
入组人数
100
试验地点
1
主要终点
To assess respiratory parameters and venous congestion in patients with hepatorenal syndrome being treated with noradrenaline and terlipressin plus albumin through ultrasound and rales score and its association with various outcomes in intensive care stay.

研究概览

简要总结

Hepatorenal syndrome (HRS) is a kidney injury caused by renal vasoconstriction due to systemic and splanchnic arterial vasodilation in advanced cirrhosis. Goal-directed therapy with albumin increases blood volume and cardiac output without affecting central venous pressure, helping maintain circulation and kidney perfusion. The ideal HRS treatment would selectively dilate renal blood vessels without affecting other circulations, especially splanchnic vessels. Both terlipressin and noradrenaline are effective vasoconstrictors for HRS. However, terlipressin may cause severe respiratory failure in volume overload, grade 3 acute-on-chronic liver failure, or pre-existing respiratory compromise. Rapid albumin administration can also worsen conditions like congestive heart failure, chronic kidney disease, and chronic liver disease. Point-of-care ultrasound (POCUS) enables bedside assessment of fluid status and organ function, helping prevent complications and guide treatment decisions. Lung ultrasound and venous excess scores can indicate fluid overload, aiding in diuretic or inotropic adjustments. The RALE score assesses lung edema severity on chest X-rays and predicts ARDS severity and outcomes. This study aims to correlate lung ultrasound and RALE scores with fluid overload in HRS patients receiving noradrenaline or terlipressin with albumin.

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 80.00 Year(s)(—)
性别
All

入选标准

  • Patients admitted to the critical care unit diagnosed as hepatorenal syndrome on treatment with terlipressin or noradrenaline plus albumin.

排除标准

  • Patients not willing for ultrasound examination.
  • Improvement in renal function after central blood volume expansion History of infection within the past week, excluding spontaneous bacterial peritonitis; History of coronary artery disease, obstructive cardiomyopathy, ventricular arrhythmia, or obliterative arterial disease of the limbs.

结局指标

主要结局

To assess respiratory parameters and venous congestion in patients with hepatorenal syndrome being treated with noradrenaline and terlipressin plus albumin through ultrasound and rales score and its association with various outcomes in intensive care stay.

时间窗: DAY 1 TO 15

次要结局

  • To determine how measurement of venous congestion and assessment of respiratory(parameters using ultrasound and rales score in patients of hepatorenal syndrome on)

研究者

发起方
AIG Hospitals
申办方类型
Other [Center of study conduct]
责任方
Principal Investigator
主要研究者

Vedaghosh Amara

AIG Hospitals

研究点 (1)

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