Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites- A Randomized Controlled Trial (I-CARE)
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups
研究概览
简要总结
The aim of the study is to assess the efficacy of intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days in comparison with large volume paracentesis on decreasing the need for repeated paracentesis by 50 % over next 3 months. The project will be conducted at ILBS between April 2020 and March 2021. The concept of the study is to evaluate the efficacy of indwelling catheter in reducing the refilling rates of ascites by 50 % over 3 months in comparison to LVPs and also in reducing the incidence and risk of PPCD. All refractory ascites patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives.
The expected outcomes are
Primary outcome: Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis after a short duration (5day) intermittent small quantity (up to 3L/ day) paracentesis through an indwelling catheter in comparison to a single large volume paracentesis in the next 3 months.
Secondary outcome:
- Proportion of cirrhotic patients with refractory ascites developing P 2 . During a 30 D, 60 D and 90 D follow up, to assess between the groups
- Need for repeated paracentesis : Number assessed
- AKI : Improvement or worsening of renal functions
- Hepatic encephalopathy: Grading as per West Haven Classification
- Hyponatremia
- Diuretic tolerability : Dose and duration tolerated
- Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm
- Transplant free survival
- Risk of procedure related complications
- Changes in MELD or CTP between the groups ( Improvement vs worsening )
- Need for hospitalization between the groups
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patients 18-70 yrs with refractory severe ascites with stable renal function (S.creatinine < 2 mg/dl).
排除标准
- •CTP >12, MELD>25
- •Prior or current Spontaneous Bacterial Peritonitis (SBP)
- •Recurrent or current overt hepatic encephalopathy
- •Serum Creatinine >2
- •HVOTO (Hepatic Venous Outflow Tract Obstruction)
- •Hepatic or extrahepatic malignancy
- •Recent UGI bleed
- •Serum Sodium < 120
结局指标
主要结局
Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups
时间窗: 3 Months
次要结局
- Diuretic tolerability : Dose tolerated in both groups(90 days)
- Number of patients required hospitalization between the groups(90 days)
- Number of participants with AKI : Improvement or worsening of renal functions in both groups(90 days)
- Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups(90 days)
- Transplant free survival in both groups(90 days)
- Number of participants develop adverse events associated with procedure in both groups(90 days)
- Number of participants with Hepatic Encephalopathy in both groups(90 days)
- Number of participants with Hyponatremia in both groups(90 days)
- Diuretic tolerability : Duration tolerated in both groups(90 days)
- Change in Model for End Stage Liver Disease Score in both groups(90 days)
- Number of participants which requires repeated paracentesis in both groups(60 days)
- Number of participants which requires for repeated paracentesis in both groups(90 days)
- Change in CTP (Child-Turcotte-Pugh) Score in both groups(90 days)