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

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)

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

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Procedure: small quantity paracentesis; Procedure: Large Volume Paracentesis

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver & Biliary Sciences
      • Contact: Dr Manasa Alla, MD; Phone Number: 01146300000; Email: manasa1512@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2020
• Primary Completion (Anticipated): May 20, 2021
• Study Completion (Anticipated): May 20, 2021

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Ascites
• Other Study ID Numbers: ILBS-Cirrhosis-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No