Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis

Acute Hemodynamic Effects of Albumin Versus Normal Saline in Patients With Cirrhosis With Ascites: A Randomized Controlled Trial

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

Study Overview

• Status: Suspended
• Conditions: Cirrhosis; Ascites
• Intervention / Treatment: Drug: 20% Human Albumin; Drug: Normal Saline

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110002
      • Department of Gastroenterology, G B Pant Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Immediately after 3 hours of infusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse effects to the drug (albumin or normal saline)	During or immediately after infusion

Collaborators and Investigators

• Sponsor: Govind Ballabh Pant Hospital
• Investigators: Principal Investigator: Shiv K Sarin, MD, DM, Govind Ballabh Pant Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Anticipated): December 1, 2008
• Study Completion (Anticipated): December 1, 2008

Study Registration Dates

• First Submitted: August 2, 2007
• First Submitted That Met QC Criteria: August 2, 2007
• First Posted (Estimate): August 3, 2007

Study Record Updates

• Last Update Posted (Estimate): October 15, 2008
• Last Update Submitted That Met QC Criteria: October 14, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Decompensated Cirrhosis with Ascites
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Ascites
• Other Study ID Numbers: 2007-PHT-01