Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04058613
Status:
UNKNOWN
Last Update Posted:
2019-09-12
First Post:
2019-08-13
Brief Title:
Effects of Maintaining Steady Albumin Levels TAT 4 on Survival and Liver Related Complications in Cirrhosis With Ascites
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Effects of Maintaining Steady Albumin Levels by Targeted Albumin Therapy TAT 4 on Survival and Liver Related Complications in Cirrhosis With Ascites and Low Serum Albumin Level- a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
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:
Investigators intend to assess the utility of regular albumin infusions to maintain a targeted serum albumin level of 40 gdl in newly detected cirrhotic patients with low albumin levels 28gdl with ascites
Detailed Description:
Cirrhosis is characterized by progressive deterioration in liver functions Livers synthetic functions are inferred by serum albumin and INR estimation Lower albumin level is a marker of severe liver disease and probability of worsening ascites hepatorenal syndrome with increased risk for infections Of the three recent RCTs on utility of long-term administration of albumin two showed improvement in survival The studies had included different patient populations diuretic refractory ascites high dose diuretics and patients on liver transplant waiting list with different albumin infusion protocols and different end-points These studies were done in advanced cases of cirrhosis There is limited data on the utility of regular albumin infusions in early hepatic decompensation albumin levels-28gdl with ascites and the effect of maintaining a targeted albumin level on survival or liver related side effects Investigators are trying to address this issue by starting regular albumin infusions at an earlier stage of liver decompensation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None