Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108355
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
2005-04-14
Brief Title:
Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis LVP in Cirrhosis
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Vasoconstrictors as Alternatives to Albumin After Large Volume Paracentesis in Cirrhosis
Status:
COMPLETED
Status Verified Date:
2014-02
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:
This clinical trial compares a combination of two drugs that constrict blood vessels Octreotide LAR and Midodrine to albumin after large volume paracentesis Subjects have cirrhosis and ascites
Detailed Description:
This prospective placebo-controlled randomized clinical trial compares the effect of a combination of vasoconstrictors octreotide plus midodrine to albumin on the time to recurrence of ascites in patients with refractory ascites treated with large volume paracentesis The treatment allocation ratio for the two treatment arms is 11 using a stratified random permuted block design Subjects are patients 18-80 years old with cirrhosis and ascites who are stratified according to the presence or absence of renal dysfunction at the time of randomization Measurements include blood pressure weight girth abdominal ultrasound forearm blood flow plasma renin activity angiotensin and aldosterone repeated during a 6 month period
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