Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis

NCT ID: NCT00511394

Last Updated: 2008-10-15

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-12-31

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

Conditions

Cirrhosis; Ascites

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

I

Infusion of 100 mL of 20% Albumin

Group Type: ACTIVE_COMPARATOR

20% Human Albumin

Intervention Type: DRUG

Infusion of 100 mL of 20% Albumin over 3 hours

II

100 mL Normal Saline

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Infusion of 100 mL of Normal Saline

Interventions

20% Human Albumin

Infusion of 100 mL of 20% Albumin over 3 hours

Intervention Type: DRUG

Normal Saline

Infusion of 100 mL of Normal Saline

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Govind Ballabh Pant Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

G B Pant Hospital

Principal Investigators

Shiv K Sarin, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Govind Ballabh Pant Hospital

Locations

Department of Gastroenterology, G B Pant Hospital

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

2007-PHT-01

Identifier Type: -

Identifier Source: org_study_id