Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511394
Status:
SUSPENDED
Last Update Posted:
2008-10-15
First Post:
2007-08-02
Brief Title:
Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis
Sponsor:
Govind Ballabh Pant Hospital
Organization:
Govind Ballabh Pant Hospital
Study Overview
Official Title:
Acute Hemodynamic Effects of Albumin Versus Normal Saline in Patients With Cirrhosis With Ascites A Randomized Controlled Trial
Status:
SUSPENDED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 Students t test or with the Wilcoxons test
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None