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

Liver Cirrhosis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04406298
• Other study ID #: ILBS-Cirrhosis-29
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2020
• Est. completion date: May 20, 2021

Study information

• Verified date: May 2020
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Manasa Alla, MD
• Phone: 01146300000
• Email: manasa1512[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 20, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Liver Cirrhosis

Intervention

Procedure:
• small quantity paracentesis
Intermittent small quantity paracentesis (upto 3L/day) for upto 5 days
• Large Volume Paracentesis
Large Volume Paracentesis > 5litres

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups		3 Months
Secondary	Number of participants which requires repeated paracentesis in both groups		30 days
Secondary	Number of participants which requires repeated paracentesis in both groups		60 days
Secondary	Number of participants which requires for repeated paracentesis in both groups		90 days
Secondary	Number of participants with AKI : Improvement or worsening of renal functions in both groups		30 days
Secondary	Number of participants with AKI : Improvement or worsening of renal functions in both groups		60 days
Secondary	Number of participants with AKI : Improvement or worsening of renal functions in both groups		90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of participants with Hyponatremia in both groups		30 days
Secondary	Number of participants with Hyponatremia in both groups		60 days
Secondary	Number of participants with Hyponatremia in both groups		90 days
Secondary	Diuretic tolerability : Dose tolerated in both groups		30 days
Secondary	Diuretic tolerability : Dose tolerated in both groups		60 days
Secondary	Diuretic tolerability : Dose tolerated in both groups		90 days
Secondary	Diuretic tolerability : Duration tolerated in both groups		30 days
Secondary	Diuretic tolerability : Duration tolerated in both groups		60 days
Secondary	Diuretic tolerability : Duration tolerated in both groups		90 days
Secondary	Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups		30 days
Secondary	Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups		60 days
Secondary	Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups		90 days
Secondary	Transplant free survival in both groups		30 days
Secondary	Transplant free survival in both groups		60 days
Secondary	Transplant free survival in both groups		90 days
Secondary	Number of participants develop adverse events associated with procedure in both groups		30 days
Secondary	Number of participants develop adverse events associated with procedure in both groups		60 days
Secondary	Number of participants develop adverse events associated with procedure in both groups		90 days
Secondary	Change in Model for End Stage Liver Disease Score in both groups	MELD Score ranges from 6 to 40	30 days
Secondary	Change in Model for End Stage Liver Disease Score in both groups	MELD Score ranges from 6 to 40	60 days
Secondary	Change in Model for End Stage Liver Disease Score in both groups	MELD Score ranges from 6 to 40	90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients required hospitalization between the groups		30 days
Secondary	Number of patients required hospitalization between the groups		60 days
Secondary	Number of patients required hospitalization between the groups		90 days