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临床试验/CTRI/2025/01/079132
CTRI/2025/01/079132尚未招募不适用

Efficacy of Empagliflozin and Midodrine in refractory ascites

Kasturba medical college MAHE1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
Mean change in abdominal girth from baseline to 12 weeks- Abdominal girth will be measured as surrogate for ascites volume.

研究概览

简要总结

After obtaining written informed consent and checking for exclusion criteria, patients having cirrhosis with refractory ascites as per criteria will be enrolled in the study. Information regarding relevant history, physical examination, demographic and laboratory parameters, grade of ascites, CTP score, MELD score, LFT, RFT will be entered in a preformatted data sheet. Study subjects will be divided into three groups on the basis of the current or planned treatment regimen with monitoring for safety and adverse events for 12 weeks: Empagliflozin group- Participants will receive empagliflozin 10mg oral tablets once daily. Midodrine group- Participants will receive Midodrine 2.5mg oral tablets thrice daily. The dose might be up titrated according to the blood pressure monitoring to maximum dose 12.5 mg three times daily. Empagliflozin and Midodrine group- Participants will receive Midodrine 2.5mg oral tablets thrice daily and empagliflozin 10mg oral tablets once daily.

Once enrolled patients will be followed up at week 4, 8 and 12. Follow up data will be recorded in a pre-designed form and outcomes will be measured. Treatment of empagliflozin will be stopped if patient developed any of the following- Attack of symptomatic hypoglycemia, hypotension not responding vasopressor agent, complicated urinary tract infection or diabetic ketoacidosis). Treatment of midodrine will be stopped if SBP is 140 mmHg.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Adults aged 18 to 75 years.
  • Decompensated liver cirrhosis with refractory ascites.

排除标准

  • Patient with contraindication to midodrine and empagliflozin.
  • Systemic Hypertension Pregnant or breastfeeding women.
  • History of hypoglycemia.
  • History of recurrent urinary tract infection.

结局指标

主要结局

Mean change in abdominal girth from baseline to 12 weeks- Abdominal girth will be measured as surrogate for ascites volume.

时间窗: 0,4,8,12 months

Mean change in body weight from baseline to 12 weeks.

时间窗: 0,4,8,12 months

Mean change in the grading of ascites

时间窗: 0,4,8,12 months

次要结局

  • Worsening of hepatic encephalopathy(Worsening of CTP and MELD function)

研究者

发起方
Kasturba medical college MAHE
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Ganesh Bhat

Manipal Academy of Higher Education

研究点 (1)

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