A study to evaluate the efficacy of SGLT2 inhibitor (Empagliflozin) as an adjunctive to SoC therapy in the management of refractory ascites in Cirrhosis
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of therapeutic paracenteses per patient and total paracentesis volume during 12 weeks
研究概览
简要总结
Ascites is the most common complication of cirrhosis, continued up to 60% of the patients with a 10 years of diagnosis. Among these 5 to 10% develop refractory ascites, defined as ascites that cannot be mobilized or recur rapidly despite dietary sodium restriction and maximal diuretic therapy. If there is a worse prognosis with median survival of less than 6 months. Current treatment plan diuretics include large-volume paracentesis, TIPS, vasoconstrictor therapy albumin infusions and diuretics. However these approaches of limitation such as procedure complication, recurrence of ascites and cost issues. Sodium glucose Co. transporter 2 (SGLT-2) inhibitors are relatively new class of antihyperglycemic agents have been shown to be renal protective and cardioprotective benefits beyond glycemic control. They are not benefiting glucose and sodium reabsorption in the proximal and ventricular producing osmotic diuresis natriuresis independent of aldosterone. This mechanism evaluation and patient with cirrhosis and ascites, with activation of the renin-angiotensin-aldosterone system aortic distance may have sclerosing pathophysiology.
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 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Cirrhosis (clinical, imaging, and/or histological) with refractory ascites (due to portal hypertension).
- •Subjects who are willing and able to comply with treatment plan, laboratory tests.
- •Subjects who are willing to provide a written informed consent.
排除标准
- •Previous history of documented hypoglycemia (in the preceding 1 month).
- •Previous history of repeated urinary tract infection (UTI) (more than 2 infections within 6 months),.
- •Pregnant or lactating females,.
- •Previous history of hypersensitivity to any SGLT2 inhibitor.
- •Serum sodium < 125 meq/L.
- •History of peripheral vascular disease (ulcer/gangrene/amputation).
- •Severe renal impairment (eGFR <30 mL/min/1.73 m²) or dialysis requirement.
- •Active alcohol use with last alcohol intake 1 month back.
- •GI bleeding in the previous 1 month.
- •Overt HE in the previous 1 month.
- •Treatment with drugs with known effects on systemic and renal hemodynamics within 7 days of inclusion, except beta blockers.
- •Previous history of diabetic ketoacidosis,.
- •Child–Pugh score of 12 or more.
- •Hepatocellular carcinoma.
- •Portal Vein Thrombosis.
- •Mixed ascites (etiology of ascites other than portal hypertension).
- •Patients opting for liver transplant or TIPS.
- •H/o pancreatitis/pancreatic surgery.
结局指标
主要结局
Number of therapeutic paracenteses per patient and total paracentesis volume during 12 weeks
时间窗: 12 weeks
次要结局
- Change in serum sodium and spot urinary sodium(Weeks 4, 8 and 12)
- Change in abdominal girth (cm) from baseline(Weeks 4, 8 and 12)
- Change in body weight (kg)(Weeks 4, 8 and 12)
- Change in eGFR from baseline(Weeks 4, 8 and 12)
- Change in HbA1c(12 weeks)
- Change in prognostic scores (CTP, MELD Na) from baseline(Weeks 4, 8 and 12)
- Incidence of AKI (as per KDIGO), serious adverse events (including SGLT2-i related AEs)(12 weeks)
- Frequency of hepatic encephalopathy(12 weeks)
- Frequency of SBP, UTI and other infections(12 weeks)
研究者
Dr Varun Mehta
DMCH Ludhiana
