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Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT00511394
First received: August 2, 2007
Last updated: October 14, 2008
Last verified: October 2008
  Purpose

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
Cirrhosis
Ascites
Drug: 20% Human Albumin
Drug: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Diagnostic
Official Title: Acute Hemodynamic Effects of Albumin Versus Normal Saline in Patients With Cirrhosis With Ascites: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • Immediate change in mean arterial pressure, cardiac output, systemic vascular resistance, pulmonary capillary wedge pressure, pulmonary vascular resistance and HVPG on infusion of 100 ml of 20% albumin or normal saline in decompensated cirrhotics [ Time Frame: Immediately after 3 hours of infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse effects to the drug (albumin or normal saline) [ Time Frame: During or immediately after infusion ] [ Designated as safety issue: Yes ]

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
Active Comparator: I
Infusion of 100 mL of 20% Albumin
Drug: 20% Human Albumin
Infusion of 100 mL of 20% Albumin over 3 hours
Placebo Comparator: II
100 mL Normal Saline
Drug: Normal Saline
Infusion of 100 mL of Normal Saline

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with cirrhosis with ascites admitted to the GE ward
  2. They require intravenous albumin therapy, for the management of their cirrhotic ascites
  3. Their serum albumin <2.8 g/dL

Exclusion Criteria:

  1. Cirrhotics without ascites
  2. Acute on chronic liver failure
  3. Serum bilirubin >3 mg/dL
  4. Hepatorenal syndrome
  5. Patients suffering from heart disease, history of allergy to albumin, pregnant women, hypertension, chronic nephritis
  6. Lack of informed written consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511394

Locations
India
Department of Gastroenterology, G B Pant Hospital
New Delhi, Delhi, India, 110002
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Investigators
Principal Investigator: Shiv K Sarin, MD, DM Govind Ballabh Pant Hospital
  More Information

No publications provided

Responsible Party: Dr S K Sarin, G B Pant Hospital
ClinicalTrials.gov Identifier: NCT00511394     History of Changes
Other Study ID Numbers: 2007-PHT-01
Study First Received: August 2, 2007
Last Updated: October 14, 2008
Health Authority: India: Ministry of Health

Keywords provided by Govind Ballabh Pant Hospital:
Decompensated Cirrhosis with Ascites

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Digestive System Diseases
Liver Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014