Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites
NCT ID: NCT04406298
Last Updated: 2020-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-07-04
2021-05-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Acute-On-Chronic Liver Failure.
NCT02467348
To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction in Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion.
NCT02467322
Body Composition Analysis in Cirrhotic Undergoing Paracentesis
NCT02022150
Efficacy & Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax.
NCT06007820
High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema
NCT06515145
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Small Quantity Paracentesis
Intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days.
small quantity paracentesis
Intermittent small quantity paracentesis (upto 3L/day) for upto 5 days
Large Volume Paracentesis
Large Volume Paracentesis \> 5 litres
Large Volume Paracentesis
Large Volume Paracentesis \> 5litres
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
small quantity paracentesis
Intermittent small quantity paracentesis (upto 3L/day) for upto 5 days
Large Volume Paracentesis
Large Volume Paracentesis \> 5litres
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ILBS-Cirrhosis-29
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.