Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation (MACHT)

This study is currently recruiting participants.
Verified March 2014 by Hospital Clinic of Barcelona
Sponsor:
Collaborators:
Maternal-Infantil Vall d´Hebron Hospital
Hospital Universitari de Bellvitge
Information provided by (Responsible Party):
Pere Gines, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00839358
First received: February 6, 2009
Last updated: March 3, 2014
Last verified: March 2014

February 6, 2009
March 3, 2014
August 2008
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00839358 on ClinicalTrials.gov Archive Site
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Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation
Midodrine and Albumin for Cirrhotic Patients in the Waiting List for Liver Transplantation

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.

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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Renal Failure
  • Hyponatremia
  • Sepsis
  • Hepatic Encephalopathy
  • Gastrointestinal Bleeding
  • Drug: albumin
    albumine 40 g every 15 days
    Other Name: Albumina Grifols
  • Drug: 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
  • Drug: Placebo
    saline solution
    Other Name: Grifols saline solution
  • 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.
    Interventions:
    • Drug: albumin
    • Drug: Midodrine
  • 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.
    Interventions:
    • Drug: albumin
    • Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
194
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with cirrhosis in the waiting list for liver transplant
  • Patients with ascites or diuretic treatment
  • To have written inform consent

Exclusion Criteria:

  • Systolic blood pressure ≥150 mmHg and or diastolic blood pressure≥90 mmHg
  • To have been treated with transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunts
  • Antibiotic treatment in the previous week before the inclusion in the study
  • Respiratory or cardiac failure
  • HIV positive
Both
18 Years to 70 Years
No
Contact: Pere Gines, MD 0034932275753 pgines@clinic.ub.es
Contact: Monica Guevara, MD 0034932275753 mguevara@clinic.ub.es
Spain
 
NCT00839358
MACHT, 07/0443, 07/90077
Yes
Pere Gines, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
  • Maternal-Infantil Vall d´Hebron Hospital
  • Hospital Universitari de Bellvitge
Principal Investigator: Pere Ginès Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP