Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis

NCT00511394 | Suspended

• 1 other identifier: 2007-PHT-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Decompensated Cirrhosis with Ascites

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse effects to the drug (albumin or normal saline)

  During or immediately after infusion

Study Arms (2)

I

ACTIVE COMPARATOR

Infusion of 100 mL of 20% Albumin

Drug: 20% Human Albumin

II

PLACEBO COMPARATOR

100 mL Normal Saline

Drug: Normal Saline

Interventions

20% Human Albumin DRUG

Infusion of 100 mL of 20% Albumin over 3 hours

I

Normal Saline DRUG

Infusion of 100 mL of Normal Saline

II

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Govind Ballabh Pant Hospital: lead

Study Sites (1)

Department of Gastroenterology, G B Pant Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

Location

MeSH Terms

Conditions

Fibrosis; Ascites

Interventions

Serum Albumin, Human; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Shiv K Sarin, MD, DM

  Govind Ballabh Pant Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 3, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 15, 2008

Record last verified: 2008-10

Locations

IN (1)