Status:
UNKNOWN
Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 paracentesi...
Eligibility Criteria
Inclusion
- Cirrhotic patients 18-70 yrs with refractory severe ascites with stable renal function (S.creatinine \< 2 mg/dl).
Exclusion
- 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
Key Trial Info
Start Date :
July 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04406298
Start Date
July 4 2020
End Date
May 20 2021
Last Update
July 30 2020
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070