FindTrial
Sign In

Removal of low quantity of abdominal fluid in the improvement of liver disease.

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
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/026068
Enrollment
200
Registered
2020-06-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Small Quantity Paracentesis: Intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days. Control Intervention1: Large Volume Paracentesis

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Cirrhotic patients 18-70 yrs with refractory severe ascites with stable renal function (S.creatinine < 2 mg/dl).

Exclusion criteria

Exclusion criteria: 1) CTP >12, MELD >25 2) Prior or current Spontaneous Bacterial Peritonitis (SBP) 3) Recurrent or current overt hepatic encephalopathy 4) Serum Creatinine >2 5) HVOTO (Hepatic Venous Outflow Tract Obstruction) 6) Hepatic or extrahepatic malignancy 7) Recent UGI bleed 8) Sepsis 9) Serum Sodium < 120

Design outcomes

Primary

MeasureTime frame
Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups Timepoint: 3 Months—

Secondary

MeasureTime frame
AKI : Improvement or worsening of renal functions in both groupsTimepoint: 30,60 and 90 days;Bacterial peritonitis : Ascitic fluid neutrophil count 250 cells/cumm in both groupsTimepoint: 30,60 and 90 days;Change in CTP and MELD Score in both groupsTimepoint: 30,60 and 90 days;Diuretic tolerability : Dose and duration tolerated in both groupsTimepoint: 30,60 and 90 days;Hepatic encephalopathy: Grading as per West Haven Classification in both groupsTimepoint: 30,60 and 90 days;Hyponatremia in both groupsTimepoint: 30,60 and 90 days;Need for hospitalization between the groupsTimepoint: 30,60 and 90 days;Need for repeated paracentesis in both groupsTimepoint: 30,60 and 90 days;Risk of procedure related complications in both groupsTimepoint: 30,60 and 90 days;Transplant free survival in both groupsTimepoint: 30,60 and 90 days—

Countries

India

Contacts

Public ContactDr Shasthry SM

Institute of Liver and Biliary Sciences

shasthry@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026