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

NCT04406298 | Unknown

• 1 other identifier: ILBS-Cirrhosis-29
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups

  3 Months

Secondary Outcomes (36)

• 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

Study Arms (2)

Small Quantity Paracentesis

EXPERIMENTAL

Intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days.

Procedure: small quantity paracentesis

Large Volume Paracentesis

ACTIVE COMPARATOR

Large Volume Paracentesis \> 5 litres

Procedure: Large Volume Paracentesis

Interventions

small quantity paracentesis PROCEDURE

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

Small Quantity Paracentesis

Large Volume Paracentesis PROCEDURE

Large Volume Paracentesis \> 5litres

Large Volume Paracentesis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhotic patients 18-70 yrs with refractory severe ascites with stable renal function (S.creatinine \< 2 mg/dl).

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Manasa Alla, MD

CONTACT

01146300000; manasa1512@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 28, 2020
• Study Start: July 4, 2020
• Primary Completion: May 20, 2021
• Study Completion: May 20, 2021
• Last Updated: July 30, 2020

Record last verified: 2020-05

Locations

IN (1)