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.

Decompensated Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467322
• Other study ID #: ILBS-Cirrhosis-003
• Status: Completed
• Phase: N/A
• First received: June 4, 2015
• Last updated: June 9, 2017
• Start date: February 23, 2015
• Est. completion date: December 15, 2016

Study information

• Verified date: October 2016
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 15, 2016
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Decompensated Cirrhosis
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PICD (Paracentesis Induced Circulatory Dysfunction).		1 Year
Secondary	Survival		28 days
Secondary	Total number of patients develop Hepatorenal Syndrome.		1 Year
Secondary	Total number of patients develop hyponatremia.		1 Year
Secondary	Changes in plasma Renin activity.		1 Year
Secondary	Changes in aldosterone with volume of ascitic fluid tap.		1 year