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Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis

Primary Purpose

Cirrhosis, Ascites

Status
Suspended
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
20% Human Albumin
Normal Saline
Sponsored by
Govind Ballabh Pant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis focused on measuring Decompensated Cirrhosis with Ascites

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gastroenterology, G B Pant Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

I

II

Arm Description

Infusion of 100 mL of 20% Albumin

100 mL Normal Saline

Outcomes

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

Secondary Outcome Measures

Adverse effects to the drug (albumin or normal saline)

Full Information

First Posted
August 2, 2007
Last Updated
October 14, 2008
Sponsor
Govind Ballabh Pant Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00511394
Brief Title
Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis
Official Title
Acute Hemodynamic Effects of Albumin Versus Normal Saline in Patients With Cirrhosis With Ascites: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Suspended
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Govind Ballabh Pant Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Ascites
Keywords
Decompensated Cirrhosis with Ascites

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Description
Infusion of 100 mL of 20% Albumin
Arm Title
II
Arm Type
Placebo Comparator
Arm Description
100 mL Normal Saline
Intervention Type
Drug
Intervention Name(s)
20% Human Albumin
Intervention Description
Infusion of 100 mL of 20% Albumin over 3 hours
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Infusion of 100 mL of Normal Saline
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Adverse effects to the drug (albumin or normal saline)
Time Frame
During or immediately after infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with cirrhosis with ascites admitted to the GE ward They require intravenous albumin therapy, for the management of their cirrhotic ascites Their serum albumin <2.8 g/dL Exclusion Criteria: Cirrhotics without ascites Acute on chronic liver failure Serum bilirubin >3 mg/dL Hepatorenal syndrome Patients suffering from heart disease, history of allergy to albumin, pregnant women, hypertension, chronic nephritis Lack of informed written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiv K Sarin, MD, DM
Organizational Affiliation
Govind Ballabh Pant Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, G B Pant Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India

12. IPD Sharing Statement

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Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis

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