An Open Label, Pilot, Randomized Controlled Trial of terlipressin in icu Versus Terlipressin in ward in the Treatment of Type 1 Hepatorenal Syndrome through assessment of respiratory parameters,lung ultrasound scores and RALES score in patients and Predictors of Response.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess respiratory parameters, side effect profile and venous congestion in patients with hepatorenal syndrome being treated with terlipressin plus albumin in intensive care vs ward 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 kidney injury caused by renal vasoconstriction due to systemic and splanchnic vasodilation in advanced cirrhosis. Albumin therapy increases central blood volume and cardiac index without affecting central venous pressure, helping maintain circulation and renal perfusion. Ideal HRS treatment would selectively vasodilate renal circulation without affecting other vascular beds. Both terlipressin and noradrenaline are effective vasoconstrictors. Unlike norepinephrine, terlipressin can be given peripherally and outside the ICU but may cause severe respiratory failure in patients with volume overload, acute-on-chronic liver failure (grade 3), or pre-existing respiratory compromise. Rapid albumin administration may worsen hypervolemic states like heart failure, CKD, and liver disease. Point-of-care ultrasound (POCUS) enables bedside physiological assessment. Lung ultrasound scores and venous excess scores help correlate fluid overload with organ function, preventing complications and improving outcomes. POCUS aids fluid management in sepsis and hypovolemia and supports clinical decisions regarding diuretics or inotropic therapy in AKI. The Radiographic Assessment of Lung Edema (RALE) score quantifies alveolar opacities on chest X-rays and independently predicts ARDS severity and outcomes. As terlipressin can be administered peripherally in wards, we aim to compare its side effect profile in ICU vs. ward settings. In the ICU, lung ultrasound is performed daily alongside RALE scoring, whereas it is less frequently used in wards. This study seeks to correlate lung ultrasound and RALE scores in predicting fluid overload in HRS patients receiving terlipressin and albumin in ICU vs. ward settings.
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 plus albumin.
排除标准
- •Patient not willing for ultrasound.
- •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, side effect profile and venous congestion in patients with hepatorenal syndrome being treated with terlipressin plus albumin in intensive care vs ward through ultrasound and rales score and its association with various outcomes in intensive care stay.
时间窗: Day 1-15
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 terlipressin plus albumin helps in evaluation of fluid overload and its impact on clinical, demographic and biochemical variables in intensive care vs ward settings.(Day 1-15)
研究者
Vedaghosh Amara
AIG Hospitals
