Vasoconstrictors as Alternatives to Albumin After LVP (Large-Volume Paracentesis) in Cirrhosis
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.
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
albumin, octreotide plus midodrine
VA Connecticut Health Care System (West Haven)
Department of Veterans Affairs
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00108355
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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).
Cell surface proteins that bind albumin with high affinity and trigger intracellular changes influencing the behavior of cells.
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)
We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are mediated in part by diminished circulatory volume and that treatment with midodrine, octreotide a...
From 1999, several studies have showed that the use of vasoconstrictors in association with albumin are effective in the treatment of hepatorenal syndrome (HRS). The rationale of the use o...
The overall objective of this proposal is to compare the effect of a combination of vasoconstrictors (midodrine + octreotide) to albumin on the time to recurrence of ascites in patients wi...
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Ascites is a common complication of cirrhosis. Sodium restriction and diuretics are the first step treatment. Refractory ascites (not responding to first step treatment) is treated with re...
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