Clinical trial NCT04406298: Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups
timeFrame: 3 Months
Secondary outcomes:
measure: Number of participants which requires repeated paracentesis in both groups
timeFrame: 30 days
measure: Number of participants which requires repeated paracentesis in both groups
timeFrame: 60 days
measure: Number of participants which requires for repeated paracentesis in both groups
timeFrame: 90 days
measure: Number of participants with AKI : Improvement or worsening of renal functions in both groups
timeFrame: 30 days
measure: Number of participants with AKI : Improvement or worsening of renal functions in both groups
timeFrame: 60 days
measure: Number of participants with AKI : Improvement or worsening of renal functions in both groups
timeFrame: 90 days
measure: Number of participants with Hepatic Encephalopathy in both groups
timeFrame: 30 days
measure: Number of participants with Hepatic Encephalopathy in both groups
timeFrame: 60 days
measure: Number of participants with Hepatic Encephalopathy in both groups
timeFrame: 90 days
measure: Number of participants with Hyponatremia in both groups
timeFrame: 30 days
measure: Number of participants with Hyponatremia in both groups
timeFrame: 60 days
measure: Number of participants with Hyponatremia in both groups
timeFrame: 90 days
measure: Diuretic tolerability : Dose tolerated in both groups
timeFrame: 30 days
measure: Diuretic tolerability : Dose tolerated in both groups
timeFrame: 60 days
measure: Diuretic tolerability : Dose tolerated in both groups
timeFrame: 90 days
measure: Diuretic tolerability : Duration tolerated in both groups
timeFrame: 30 days
measure: Diuretic tolerability : Duration tolerated in both groups
timeFrame: 60 days
measure: Diuretic tolerability : Duration tolerated in both groups
timeFrame: 90 days
measure: Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups
timeFrame: 30 days
measure: Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups
timeFrame: 60 days
measure: Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups
timeFrame: 90 days
measure: Transplant free survival in both groups
timeFrame: 30 days
measure: Transplant free survival in both groups
timeFrame: 60 days
measure: Transplant free survival in both groups
timeFrame: 90 days
measure: Number of participants develop adverse events associated with procedure in both groups
timeFrame: 30 days
measure: Number of participants develop adverse events associated with procedure in both groups
timeFrame: 60 days
measure: Number of participants develop adverse events associated with procedure in both groups
timeFrame: 90 days
measure: Change in Model for End Stage Liver Disease Score in both groups
timeFrame: 30 days
measure: Change in Model for End Stage Liver Disease Score in both groups
timeFrame: 60 days
measure: Change in Model for End Stage Liver Disease Score in both groups
timeFrame: 90 days
measure: Change in CTP (Child-Turcotte-Pugh) Score in both groups
timeFrame: 30 days
measure: Change in CTP (Child-Turcotte-Pugh) Score in both groups
timeFrame: 60 days
measure: Change in CTP (Child-Turcotte-Pugh) Score in both groups
timeFrame: 90 days
measure: Number of patients required hospitalization between the groups
timeFrame: 30 days
measure: Number of patients required hospitalization between the groups
timeFrame: 60 days
measure: Number of patients required hospitalization between the groups
timeFrame: 90 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: