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Incidence And Outcome of paracentesis (Removal of fluid from the abdomen) induced complications in liver Disease.

To study the Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction in Acute on chronic Liver failure Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011956
Enrollment
80
Registered
2018-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Decompensated Cirrhosis Health Condition 2: K740- Hepatic fibrosis

Interventions

Intervention1: Albumin: MVP (Moderate Volume Paracentesis) of less than 5 liters with iv albumin at a dose 8 gms/l of ascitic fluid. Control Intervention1: No Albumin: MVP(Moderate Volume Paracentesis

Sponsors

Institute of liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) All Cirrhotics decompensated with ascites admitted in the hospital. 2) All patients with acute hepatic insult manifesting as jaundice (Sr. Bil. >= 5 mg/dL) and coagulopathy (INR>=1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease (ACLF) admitted in the hospital. 3) Grade II/III ascites 4) Need for paracentesis

Exclusion criteria

Exclusion criteria: 1) Age 75 years 2) Hepatocellular carcinoma 3) Non cirrhotic ascites such as malignancy or tubercular peritonitis 4) Serum Cr >1.5mg% 5) Refractory septic shock 6) Grade III/IV hepatic encephalopathy 7) Abdominal wall cellulitis 8) Active variceal bleed 9) Respiratory, cardiac and renal failure 10 Refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction)Timepoint: 28 days—

Secondary

MeasureTime frame
Changes in aldosterone with volume of ascitic fluid tap.Timepoint: 1 year;Changes in plasma Renin activity.Timepoint: 1 year;SurvivalTimepoint: 28 days;Total number of patients develop Hepatorenal Syndrome.Timepoint: 1 year;Total number of patients develop hyponatremia.Timepoint: 1 year—

Countries

India

Contacts

Public ContactDr Vinod Arora

Institute of Liver and Biliary Sciences

johncenaucms@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026