Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites

Study Overview
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Brief Summary
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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: 1. 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

Official Title
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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)

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Procedure: small quantity paracentesis
* Procedure: Large Volume Paracentesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cirrhotic patients 18-70 yrs with refractory severe ascites with stable renal function (S.creatinine < 2 mg/dl). Exclusion Criteria: 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 Sepsis Serum Sodium < 120

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small Quantity Paracentesis<br>Intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days. | Procedure: small quantity paracentesis<br>* Intermittent small quantity paracentesis (upto 3L/day) for upto 5 days<br>|
| Active Comparator: Large Volume Paracentesis<br>Large Volume Paracentesis > 5 litres | Procedure: Large Volume Paracentesis<br>* Large Volume Paracentesis > 5litres<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants which requires repeated paracentesis in both groups |  | 30 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 | 
| Number of participants with AKI : Improvement or worsening of renal functions in both groups |  | 30 days | 
| Number of participants with AKI : Improvement or worsening of renal functions in both groups |  | 60 days | 
| Number of participants with AKI : Improvement or worsening of renal functions in both groups |  | 90 days | 
| Number of participants with Hepatic Encephalopathy in both groups | Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups | 30 days | 
| Number of participants with Hepatic Encephalopathy in both groups | Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups | 60 days | 
| Number of participants with Hepatic Encephalopathy in both groups | Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups | 90 days | 
| Number of participants with Hyponatremia in both groups |  | 30 days | 
| Number of participants with Hyponatremia in both groups |  | 60 days | 
| Number of participants with Hyponatremia in both groups |  | 90 days | 
| Diuretic tolerability : Dose tolerated in both groups |  | 30 days | 
| Diuretic tolerability : Dose tolerated in both groups |  | 60 days | 
| Diuretic tolerability : Dose tolerated in both groups |  | 90 days | 
| Diuretic tolerability : Duration tolerated in both groups |  | 30 days | 
| Diuretic tolerability : Duration tolerated in both groups |  | 60 days | 
| Diuretic tolerability : Duration tolerated in both groups |  | 90 days | 
| Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups |  | 30 days | 
| Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups |  | 60 days | 
| Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups |  | 90 days | 
| Transplant free survival in both groups |  | 30 days | 
| Transplant free survival in both groups |  | 60 days | 
| Transplant free survival in both groups |  | 90 days | 
| Number of participants develop adverse events associated with procedure in both groups |  | 30 days | 
| Number of participants develop adverse events associated with procedure in both groups |  | 60 days | 
| Number of participants develop adverse events associated with procedure in both groups |  | 90 days | 
| Change in Model for End Stage Liver Disease Score in both groups | MELD Score ranges from 6 to 40 | 30 days | 
| Change in Model for End Stage Liver Disease Score in both groups | MELD Score ranges from 6 to 40 | 60 days | 
| Change in Model for End Stage Liver Disease Score in both groups | MELD Score ranges from 6 to 40 | 90 days | 
| Change in CTP (Child-Turcotte-Pugh) Score in both groups | Child class A: < 7 points. Child class B: 7-9 points. Child class C: ≥10 points | 30 days | 
| Change in CTP (Child-Turcotte-Pugh) Score in both groups | Child class A: < 7 points. Child class B: 7-9 points. Child class C: ≥10 points | 60 days | 
| Change in CTP (Child-Turcotte-Pugh) Score in both groups | Child class A: < 7 points. Child class B: 7-9 points. Child class C: ≥10 points | 90 days | 
| Number of patients required hospitalization between the groups |  | 30 days | 
| Number of patients required hospitalization between the groups |  | 60 days | 
| Number of patients required hospitalization between the groups |  | 90 days |