Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis
Status:
Suspended
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
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