Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis
Information source: Govind Ballabh Pant Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cirrhosis; Ascites
Intervention: 20% Human Albumin (Drug); Normal Saline (Drug)
Phase: N/A
Status: Suspended
Sponsored by: Govind Ballabh Pant Hospital Official(s) and/or principal investigator(s): Shiv K Sarin, MD, DM, Principal Investigator, Affiliation: Govind Ballabh Pant Hospital
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
Clinical Details
Official title: Acute Hemodynamic Effects of Albumin Versus Normal Saline in Patients With Cirrhosis With Ascites: A Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic
Primary outcome: 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: Adverse effects to the drug (albumin or normal saline)
Eligibility
Minimum age: 12 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Department of Gastroenterology, G B Pant Hospital, New Delhi, Delhi 110002, India
Additional Information
Starting date: May 2007
Last updated: October 14, 2008
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