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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States
Time to Recurrence of Ascites.
Comparison between Albumin (Control group) and Vasoconstrictor (Treatment group)
Time frame: Variable depending on the patient, average 10 days
Development of Post-paracentesis Circulatory Dysfunction (PCD)
Defined as an increase in Plasma Renin Activity (PRA) by \>50% from baseline to a level \> 4 ng/mL/h at post-paracentesis day
Time frame: 6 days after paracentesis
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Oral tablet (Midodrine placebo) three times a day
Octreotide LAR 20 mg intramuscular injection every 30 days
Saline intramuscular injection 5 cc every 30 days.
Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.