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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

NCT04406298 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-07-30

No results posted yet for this study

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

Interventions

PROCEDURE

small quantity paracentesis

Intermittent small quantity paracentesis (upto 3L/day) for upto 5 days

PROCEDURE

Large Volume Paracentesis

Large Volume Paracentesis \> 5litres

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-04
Primary Completion
2021-05-20
Completion
2021-05-20

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04406298 on ClinicalTrials.gov