Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00511394
Recruitment Status : Suspended
First Posted : August 3, 2007
Last Update Posted : October 15, 2008
Information provided by:
Govind Ballabh Pant Hospital

August 2, 2007
August 3, 2007
October 15, 2008
May 2007
December 2008   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00511394 on Archive Site
Adverse effects to the drug (albumin or normal saline) [ Time Frame: During or immediately after infusion ]
Same as current
Not Provided
Not Provided
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
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
  • Cirrhosis
  • Ascites
  • Drug: 20% Human Albumin
    Infusion of 100 mL of 20% Albumin over 3 hours
  • Drug: Normal Saline
    Infusion of 100 mL of Normal Saline
  • Active Comparator: I
    Infusion of 100 mL of 20% Albumin
    Intervention: Drug: 20% Human Albumin
  • Placebo Comparator: II
    100 mL Normal Saline
    Intervention: Drug: Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2008
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 75 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dr S K Sarin, G B Pant Hospital
Govind Ballabh Pant Hospital
Not Provided
Principal Investigator: Shiv K Sarin, MD, DM Govind Ballabh Pant Hospital
Govind Ballabh Pant Hospital
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP