Vasoconstrictors as Alternatives to Albumin After LVP (Large-Volume Paracentesis) in Cirrhosis
Summary
This clinical trial compares a combination of two drugs that constrict blood vessels (Sandostatin LAR and Midodrine) to albumin after large volume paracentesis. Subjects have cirrhosis and ascites.
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 1:1 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 Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Ascites
Intervention
albumin, octreotide plus midodrine
Location
VA Connecticut Health Care System (West Haven)
West Haven
Connecticut
United States
06516
Status
Recruiting
Source
Department of Veterans Affairs
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00108355
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Hypoalbuminemia
A condition in which albumin level in blood (SERUM ALBUMIN) is below the normal range. Hypoalbuminemia may be due to decreased hepatic albumin synthesis, increased albumin catabolism, altered albumin distribution, or albumin loss through the urine (ALBUMINURIA).
Receptors, Albumin
Cell surface proteins that bind albumin with high affinity and trigger intracellular changes influencing the behavior of cells.
Midodrine
An ethanolamine derivative that is an adrenergic alpha agonist. It is used as a vasoconstrictor agent in the treatment of hypotension.
Serum Albumin, Bovine
Serum albumin from cows, commonly used in in vitro biological studies. (From Stedman, 25th ed)
Serum Albumin, Radio-iodinated
Normal human serum albumin mildly iodinated with radioactive iodine (131-I) which has a half-life of 8 days, and emits beta and gamma rays. It is used as a diagnostic aid in blood volume determination. (from Merck Index, 11th ed)
Clinical Trials
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PubMed Articles
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