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.

NCT ID: NCT02467322

Last Updated: 2017-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-23

Study Completion Date

2016-12-15

Brief Summary

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All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016. Decompensated cirrhosis patients will be randomized into Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres with iv albumin at a dose 8 gms/l of ascitic fluid Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres without albumin .

Detailed Description

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Conditions

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Decompensated Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Albumin

MVP (Moderate Volume Paracentesis) of less than 5 liters with iv albumin at a dose 8 gms/l of ascitic fluid.

Group Type EXPERIMENTAL

Albumin

Intervention Type DRUG

MVP of less than 5 liters with iv albumin at a dose 8 gms/L of ascitic fluid.

ascitic fluid

Intervention Type DRUG

No Albumin

MVP(Moderate Volume Paracentesis) of less than 5 liters without albumin.

Group Type ACTIVE_COMPARATOR

ascitic fluid

Intervention Type DRUG

Interventions

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Albumin

MVP of less than 5 liters with iv albumin at a dose 8 gms/L of ascitic fluid.

Intervention Type DRUG

ascitic fluid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. All Cirrhotics decompensated with ascites admitted in the hospital.
2. Grade II/III ascites
3. Need for paracentesis.

Exclusion Criteria

1. Age \<12 or \> 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-Cirrhosis-003

Identifier Type: -

Identifier Source: org_study_id

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