NCT05430243已完成2 期
Empagliflozin in the Management of Cirrhosis-related Refractory Ascites: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- No need for paracentecis
研究概览
简要总结
The aim of the present study is to investigate the safety, efficacy and cost-effectiveness of empagliflozin, a sodium glucose transporter 2 inhibitor, as an add on therapy to the standard care for refractory ascites in patients with liver cirrhosis
详细描述
Midodrine will be added if the blood pressure less than 100/70 mmHg during the follow up period (start by dose 5 mg three times daily and up titrate the dose according to the blood pressure monitoring to maximum dose 12.5 mg three times daily.
- Treatment of empagliflozin will be stopped if patient developed any of the following (attack of symptomatic hypoglycemia, hypotention not responding vasopresser agent, complicated urinary tract infection or attack of diabetic ketoascidosis) .
- The dose of diuretics will be reduced if marked weight reduction occurred (more than 0.5 kilogram/day in patient with ascites only or more than 1 killogram /day in patients with ascites and lower limb edema).
- The diuretics will be stopped temporally if any of the following (renal impairment, attack of hepatic encephalopathy, severe electrolyte imbalance) and permanently if the urine sodium < 30 mEq per day or there are intolerable side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 years old.
- •Ability to give a written informed consent.
- •Decompensated liver cirrhosis complicated with ascites.
- •Diagnosis of refractory ascites has made 3 months before informed consent which defined as one of the following(6)
- •Ascites that cannot be mobilized or the early recurrence of which cannot be prevented despite moderate salt restriction and maximum dose of diuretics ( furosemide 160 mg or equivalent and spironolactone 400mg)
- •Ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of the development of diuretic-induced complications that preclude the use of an effective diuretic dosage.
排除标准
- •History of any attack of hypoglycemia (defined as serum glucose less than 70 mg/dl) either symptomatic or a symptomatic.
- •Blood pressure below 90/60 or History of Hypotension requiring high dose of vasopressor therapy (more than 15mg midodrine /day)
- •Patients who receive non-selective B-blockers.
- •History of recurrent urinary tract infection defined as more than 2 infections in last 6 months
- •Pregnancy and breast feeding
- •History of hypersensitivity to any SGLT2 inhibitor
- •Presence of hepatocellular carcinoma or any other malignancy.
- •eGFR below 30 ml/min using Modification of Diet in Renal Disease study (MDRD)
- •Patients with history of diabetes mellitus complicated with diabetic ketoacidois (DKA) or patients have any risk factors for DKA
- •History of alcohol intake
- •Modified Child-Pugh score 12 or more.
研究组 & 干预措施
Empagliflozin group
Experimental
干预措施: Empagliflozin 10 MG (Drug)
Empagliflozin group
Experimental
干预措施: Diuretics (Drug)
standard treatment only group
Active Comparator
干预措施: Diuretics (Drug)
结局指标
主要结局
No need for paracentecis
时间窗: 3 months
次要结局
未报告次要终点
研究者
Ahmed Kamal
Lecturer
Alexandria University
研究点 (1)
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