Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
The aim of this study is to evaluate the effect of prolonged administration of albumin and
midodrine on the prevention of complications (renal failure, sepsis, hemorrhage, hepatic
encephalopathy and hyponatremia) in patients with cirrhosis in the waiting list for liver
transplantation. One hundred and ninety four patients with cirrhosis and awaiting a liver
transplantation will include in the study. Patients will be randomized to receive albumin and
midodrine (treatment group) or administration of placebo (saline for albumine) and tablets
with excipients without midodrine (control group). Patients will be followed-up during 12th
months. In the treatment group albumin will be given at a dose of 40g every 15 days and
midodrine 5mg tid, in addition with lactitol (conventional doses) and the specific treatment
that patients require by cirrhosis. The group control will receive placebo in the same way
than the treatment group in addition with lactitol and the specific treatment that they
require by their disease. In all the patients liver and renal function test, hormones
determination (renin, aldosterone, noradrenaline), and cytokines will be determined in basal
conditions. All these determinations will be repeated at month 1st,3rd, 6th and 12th months.
Before the inclusion in the study neuropsychological test and critical flicker test will be
performed to diagnose minimum EH. These tests will be repeated at 3rd, 6th and 12th months.
All the determinations will be repeated at any time that the patients develop any
complication considered as an end point. In baseline conditions and at 3rd and 6th months a
questionnaire of quality of life (SF36) will be performed. During a year of follow-up the
number of paracentesis that patients require, the incidence of renal failure and EH and their
relationship with hormonal activity and cytokine levels, free transplant survival and quality
of life will be recorded.
Phase:
Phase 4
Details
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborators:
Hospital Universitari de Bellvitge Maternal-Infantil Vall d´Hebron Hospital