Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation (MACHT)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Midodrine and Albumin for Cirrhotic Patients in the Waiting List for Liver Transplantation|
- To evaluate complications (renal failure, hepatic encephalopathy, hyponatremia, infection and gastrointestinal bleeding) in patients with cirrhosis awaiting for liver transplant. [ Time Frame: When 97 patients are included (% of the whole population) ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Albumin plus midodrine
Albumin 40 g every 15 days during 1 year or until liver transplantation. Midodrine 5mg/8h. It can be increased according the value of mean arterial pressure. If there is no increase (defined as at least 10mmHGin MAP)midodrine can be increased at a dose of 10mg/8h. This treatment will be given during 1 year or until liver transplantation.
albumine 40 g every 15 days
Other Name: Albumina GrifolsDrug: Midodrine
Midodrine 5mg/8 hs, can be increase up to 8mg/8hs if there is a lack of increase in at least 10mmHg in mean arterial pressure after 15 days of treatment.
Other Name: Gutron
Placebo Comparator: salin solution plus pills
Placebo of albumin in the same schedule thats in arm 1; placebo of midodrine in the same schedule thats in arm 1.
albumine 40 g every 15 days
Other Name: Albumina GrifolsDrug: Placebo
Other Name: Grifols saline solution
End point: To evaluate the effect of long term administration of albumin and midodrine on the prevention of complications associated with cirrhosis in patients with cirrhosis awaiting for liver transplantation.
Secondary end points:
- To evaluate improvement in the ascites control
- To evaluate survival at 6 and 12 months.
- To evaluate the relationship between the development of complications and the activity of vasoconstrictor systems( renin, aldosterone and norepinephrine) as well as the levels of cytokines (TNF, IL6 and IL10)
- To evaluate quality of life
- To evaluate the presence and outcome of MHE
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839358
|Contact: Pere Gines, MDfirstname.lastname@example.org|
|Contact: Monica Guevara, MDemail@example.com|
|Villarroel 170, Barcelona, Spain, 08870|
|Contact: Pere Gines 0034972275753 firstname.lastname@example.org|
|Sub-Investigator: Juan Cordoba|
|Sub-Investigator: Xavier Xiol|
|Sub-Investigator: Monica Guevara|
|Principal Investigator:||Pere Ginès||Hospital Clinic of Barcelona|