Mechanism and the Effect of Midodrine on Portal Pressures in Patients With Cirrhosis
Status:
Withdrawn
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
Ascites is a frequent complication of patients with portal hypertension. As portal
hypertension progresses, a percentage of these patients develop refractory ascites.
Management options at that point include either TIPS or intermittent large volume
paracentesis (LVP), with its attendant risks, Portal hypertension is accompanied by systemic
circulatory dysfunction (decreased systemic vascular resistance and systolic BP), which is
exacerbated by large volume paracentesis, with resultant renal and cardiac dysfunction. There
are limited options for managing patients with acute decompensation, such as hepatorenal
syndrome, although midodrine and other vasoconstrictors have been used in such patients.
Midodrine has not been used as a possible therapeutic for ascites. Midodrine however, has
been found to change the hemodynamics related to portal hypertension and ascites. There has
been also change in mediators related to renal and circulation in studies of short duration
(7 days) but not found in studies of 1 month duration, however the clinical effects of
midodrine is found for longer duration in other similar conditions.
The purpose of the study is to assess the utility of midodrine in patients with obvious
systemic circulatory dysfunction (hypotension) in improving the outcome of patients with
refractory ascites and change in hemodynamic parameters and its mediators.
Specific endpoints include:
1) an objective reduction of the volume/rate of accumulation of ascites and 2) a decrease in
the frequency of LVP.