RANDOMIZED CONTROL TRIAL OF SGLT-2 INHIBITOR (DAPAGLIFLOZIN) IN CIRRHOSIS PATIENTS WITH REFRACTORY ASCITES: A PILOT RCT DAPRA-CLD
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Comparison of control of ascites at 3 months between the 2 groups
研究概览
简要总结
Dapagliflozin, a Sodium Glucose Linked Transporter-2 (SGLT-2) inhibitor, used in Type 2 Diabetes Mellitus, is known for its cardiovascular benefits (4), renal benefits (5) and has minimal risk of hypoglycemia due to its insulin-independent mechanism of action (6). Its natriuretic effects have shown promise in reducing hospitalizations in heart failure patients, regardless of diabetes status (7). In a recent small case series, SGLT-2 inhibitors, including dapagliflozin, have resulted in improvements in fluid retention and serum sodium levels in patients with cirrhosis, without causing acute kidney injury or encephalopathy (8).
However, there remains a dearth of well-designed clinical trials evaluating the efficacy of dapagliflozin specifically in cirrhosis patients with refractory ascites. Thus, the objective of this randomized controlled study is to assess the efficacy of dapagliflozin in cirrhosis patients with refractory ascites.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Cirrhosis patients with refractory ascites with Child-Turcotte-Pugh B7-C11 class Hepatic Cirrhosis (moderate-severe impaired liver function).
排除标准
- •Portal vein thrombosis Hepatocellular carcinoma.
- •Active alcoholism with last alcohol intake 1 month back Gastrointestinal bleeding in the preceding 1 month Overt hepatic encephalopathy in the preceding 1-month Documented hypoglycaemia in the preceding 1-month Serum sodium less than 125 meq/L History of skeletal fracture in the preceding year or any past history of fragility fracture History of peripheral vascular disease Acute kidney injury as defined by the International Club of Ascites criteria Spontaneous Bacterial Peritonitis within 1-month preceding the study Anatomic urologic defects that predispose to urinary tract infection Mixed ascites (additional etiology of ascites apart from portal hypertension) Any severe extra hepatic condition including respiratory and cardiac failure Acute-on-chronic liver failure as per either the APASL or CANONIC criteria Treatment with drug with known effects on systemic and renal hemodynamics within 7 days of inclusion except beta-blockers Patients opting for a liver transplant or TIPS Refusal to give consent.
结局指标
主要结局
Comparison of control of ascites at 3 months between the 2 groups
时间窗: 3 months
次要结局
- 1. Change in eGFR measured by MDRD-6 at 1, 2 and 3 months(2. Change in urine output at 2 -weeks, 1, 2 and 3 months)
研究者
Dr Shalimar
All India Institute of Medical Sciences