AN OPEN-LABELLED BLINDED ENDPOINT RANDOMISED TRIAL (PROBE) TO ASSESS THE EFFICACY AND KINETICS OF MIDODRINE IN CIRRHOSIS ASSOCIATED REFRACTORY ASCITES PATIENTS
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Control of ascites determined by change in weight, need of LVP, USG imaging.
研究概览
简要总结
All the patients with cirrhosis-associated refractory ascites who were admitted and came in OPD at Amrita Hospital will be screened. Those who fulfill the study inclusion criteria will be invited to participate in the study. A detailed, informed consent form will be provided. After obtaining consent from the patient (or a family member as appropriate), they will be enrolled in either the study group (Midodrine + Standard Medical Therapy) or the Standard Medical Therapy group alone (SMT) as per computer-generated randomization. In each arm, there are 40 patients, for a total of 80.
All enrolled patients in the study group will be given midodrine 5mg three times daily, and the dose is increased by 2.5mg every fourth day until they achieve a mean arterial pressure of >82 mmHg, along with standard medical therapy. The standard medical therapy group for refractory ascites includes fluid management, ascites drainage, paracentesis, a low-sodium diet, and diuretics.
The 8-ml blood sample will be collected from the patients in the study group on any day after the second day of administration of midodrine for therapeutic drug monitoring.
The effectiveness of midodrine will be evaluated based on the following factors: the need for large volume paracentesis, percentage change in body weight, USG, renal function, liver function, urine sodium and potassium, serum electrolytes, and adverse events that occur over the course of treatment.
After 28 days, the study will be terminated.
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
- •Definite history of cirrhosis with refractory ascites, ascites evidenced by USG and stable renal function.
排除标准
- •Heart failure with ascites, serum creatinine greater than 1.5 mg/dl, anuria, gastrointestinal bleeding, HRS, grade 2 encephalopathy.
结局指标
主要结局
Control of ascites determined by change in weight, need of LVP, USG imaging.
时间窗: 28 days
次要结局
- Determine serum drug concentration of midodrine, responsiveness to midodrine by assessing mean arterial pressure, urine sodium and pottassium, renal function and liver function, assess change in serum sodium and pottasium and to assess treatment emergent ADRs.(28 days)
研究者
Dr ARUN VALSAN
Amrita Institute of Medical Sciences and Research Center, Kochi