NCT04406298

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
PROCEDURE	small quantity paracentesis	Intermittent small quantity paracentesis (upto 3L/day) for upto 5 days
PROCEDURE	Large Volume Paracentesis	Large Volume Paracentesis \> 5litres

Timeline

• Start date: 2020-07-04
• Primary completion: 2021-05-20
• Completion: 2021-05-20
• First posted: 2020-05-28
• Last updated: 2020-07-30

Locations

1 site across 1 country: India