A Prospective randomized controlled Open labelled two arm pilot study with blinded endpoints (PROBE) to evaluate the effect of Torsemide spironolactone vs Furosemide spironolactone combination in cirrhotic patients with newly diagnosed ascites
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy to control ascites in patients with cirrhosis using the mean change in body weight and need for large volume paracentesis
研究概览
简要总结
All the cirrhotic patients with newly diagnosed ascites presenting to Hepatology and Gastroenterology department f Amrita hospital will be screened. Those who fulfill the inclusion criteria of the study will be invited to participate in the study. A detailed consent form will be provided and after obtaining consent from patient they will be enrolled into either the control arm recieving Furosemide 20mg+ spironolactone 50mg or the study arm recieving Torsemide 10mg+ Spironolactone 50mg. As per the pre prepared computer generated randomisation sequence in the ratio 1:1. All enrolled patients will be given medications for 28days. Patients will be taught how to measure abdominal girth and body weight. 5g premeasured salt will be given to the patients. After 4 days of diuretic therapy the following will be determined. Urine Na+/K+, abdominal girth, body weight, RFT, Serum electrolytes. If Urine Na+/K+ >1, 2 kg body weight loss occurs - Diuretic sensitive, and SRD fllowedIf Urine Na+/K+>1, less than 2 kg weight loss occurs - Diuretic Sensitive and SRD sensitiveIf Urine Na+/K+<1 - Diuretic dose resistsnt, dose escalation required The dose escalation according to the ascitic control determined by body weight and USG imaging will be left to clinicians discretion. The study drugs will be administered once daily for 28days and followup will be done on every 4th day. The TDM of both drugs will be assessed.
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
- •1 Cirrhosis diagnosed by imaging and or biopsy with newly diagnosed ascites with Ascitic fluid Protein less than 2.5g per dL, SAAG more than 1.1 2 Cirrhosis as evidenced by USG or Cross-Sectional imaging 3 Serum Creatinine less than 1.5mg per dl 4 Informed consent.
排除标准
- •1 Spontaneous bacterial peritonitis 2 Pregnancy 3 Serum Creatinine more than 1.5 mg per dl
- •Urine albumin is to Creatinine ratio more than 500mg per gm creatinine 5 Poorly controlled diabetes, fasting glucose more than 200mg per dl 6.SIADH, as per Bartter Schwartz criteria 7.Anuria, urine volume less than 100ml per day 8.Cerebrovascular accident within 30 days prior to the study medication.
结局指标
主要结局
Efficacy to control ascites in patients with cirrhosis using the mean change in body weight and need for large volume paracentesis
时间窗: 28 days
次要结局
- 1.To assess the therapeutic drug monitoring of both drugs(2.To study the treatment emergent complications of therapy)
研究者
Dr Arun Valsan
Amrita Institute of Medical Sciences and research Centre, Kochi