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.

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02467322

Enrollment

Registered

2015-06-10

Start date

2015-02-23

Completion date

2016-12-15

Last updated

2017-06-12

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

Conditions

Decompensated Cirrhosis

Brief 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 .

Interventions

DRUGAlbumin

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

DRUGascitic fluid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction).	1 Year

Secondary

Measure	Time frame
Survival	28 days
Total number of patients develop Hepatorenal Syndrome.	1 Year
Total number of patients develop hyponatremia.	1 Year
Changes in plasma Renin activity.	1 Year
Changes in aldosterone with volume of ascitic fluid tap.	1 year

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026