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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02467322 |
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Date of registration:
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04/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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 |
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Date of first enrolment:
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February 23, 2015 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02467322 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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India
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Decompensated Cirrhosis
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Intervention(s)
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Drug: Albumin
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Drug: ascitic fluid
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Primary Outcome(s)
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Incidence of PICD (Paracentesis Induced Circulatory Dysfunction).
[Time Frame: 1 Year]
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Secondary Outcome(s)
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Changes in aldosterone with volume of ascitic fluid tap.
[Time Frame: 1 year]
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Survival
[Time Frame: 28 days]
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Changes in plasma Renin activity.
[Time Frame: 1 Year]
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Total number of patients develop Hepatorenal Syndrome.
[Time Frame: 1 Year]
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Total number of patients develop hyponatremia.
[Time Frame: 1 Year]
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Secondary ID(s)
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ILBS-Cirrhosis-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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