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Sponsored by: |
Govind Ballabh Pant Hospital |
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Information provided by: | Govind Ballabh Pant Hospital |
ClinicalTrials.gov Identifier: | NCT00511394 |
Cirrhosis is frequently complicated by derangement of body fluid homeostasis resulting in accumulation of large amounts of extracellular fluid in the peritoneal cavity (ascites) and interstitial tissue (edema). Studies showed that patients with cirrhosis and ascites have marked circulatory dysfunction. Albumin infusions have been used for many years in the management of patients with cirrhosis and ascites in an attempt to reduce the formation of ascites and/or improve circulatory and renal function. While some of these indications for albumin infusions are supported by the results of randomised studies, others are based on clinical experience and have not been proved in prospective investigations. Therefore, the use of albumin infusions in patients with cirrhosis is controversial. Recently, this debate has been fostered by the high cost and limited availability of albumin and the results of a meta-analysis showing that albumin administration may increase mortality in critically ill patients. In cirrhotics, there is a significant improvement in the low effective arterial blood volume, which may be important in the prevention of circulatory dysfunction and in preventing renal impairment. However, in an already fluid overload state such as that of cirrhosis, albumin infusion predisposes the individual to develop pulmonary edema. There is no study demonstrating acute effect of albumin infusion on hemodynamic parameters, in cirrhotic patients. Neither is there is data concerning comparison between albumin and normal saline. It is postulated that it may increase portal pressure thereby increasing the risk of variceal bleed. This study hypothesizes that albumin infusion might lead to alteration in portal and pulmonary hemodynamics in decompensated cirrhotic patients. Included patients of cirrhosis with ascites (based on inclusion and exclusion criteria) will undergo baseline investigations (systemic hemodynamics, pulmonary hemodynamics, portal hemodynamics). They will be randomized into two groups, each of 8. One group will receive infusion of 100 ml 20% albumin over 3 hours, and the other will receive infusion of 100 ml normal saline over 3 hours. Repeat hemodynamic studies will be performed after the infusion finishes. All results will be expressed as mean ± SD or frequency (%). Comparisons will be performed by the Student's t test or with the Wilcoxon's test
Condition | Intervention |
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Cirrhosis Ascites |
Drug: 20% Human Albumin Drug: Normal Saline |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Acute Hemodynamic Effects of Albumin Versus Normal Saline in Patients With Cirrhosis With Ascites: A Randomized Controlled Trial |
Estimated Enrollment: | 16 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Active Comparator
Infusion of 100 mL of 20% Albumin
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Drug: 20% Human Albumin
Infusion of 100 mL of 20% Albumin over 3 hours
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II: Placebo Comparator
100 mL Normal Saline
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Drug: Normal Saline
Infusion of 100 mL of Normal Saline
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Ages Eligible for Study: | 12 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India, Delhi | |
Department of Gastroenterology, G B Pant Hospital | |
New Delhi, Delhi, India, 110002 |
Principal Investigator: | Shiv K Sarin, MD, DM | Govind Ballabh Pant Hospital |
Responsible Party: | G B Pant Hospital ( Dr S K Sarin ) |
Study ID Numbers: | 2007-PHT-01 |
Study First Received: | August 2, 2007 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00511394 |
Health Authority: | India: Ministry of Health |
Decompensated Cirrhosis with Ascites |
Liver Diseases Digestive System Diseases Fibrosis Ascites Liver Cirrhosis |
Pathologic Processes |