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Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation (MACHT)
This study is currently recruiting participants.
Verified by Hospital Clinic of Barcelona, February 2009
First Received: February 6, 2009   No Changes Posted
Sponsors and Collaborators: Hospital Clinic of Barcelona
Maternal-Infantil Vall d´Hebron Hospital
Hospital Universitari de Bellvitge
Information provided by: Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00839358
  Purpose

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.


Condition Intervention Phase
Renal Failure
Hyponatremia
Sepsis
Hepatic Encephalopathy
Variceal Bleeding
Drug: albumin
Drug: Midodrine
Drug: Placebo
Phase IV

MedlinePlus related topics: Cirrhosis Kidney Failure Liver Transplantation Sepsis
Drug Information available for: Midodrine Midodrine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title: Midodrine and Albumin for Cirrhotic Patients in the Waiting List for Liver Transplantation

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 194
Study Start Date: August 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Albumin plus midodrine: Active Comparator
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.
Drug: albumin
albumine 40 g every 15 days
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.
salin solution plus pills: Placebo Comparator
Placebo of albumin in the same schedule thats in arm 1; placebo of midodrin in the same schedule thats in arm 1.
Drug: albumin
albumine 40 g every 15 days
Drug: Placebo
saline solution

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839358

Contacts
Contact: Pere Gines, MD 0034932275753 pgines@clinic.ub.es
Contact: Monica Guevara, MD 0034932275753 mguevara@clinic.ub.es

Locations
Spain, Barcelona
Hospital Clinic Recruiting
Villarroel 170, Barcelona, Spain, 08870
Contact: Pere Gines     0034972275753     pgines@clinic.ub.es    
Sub-Investigator: Juan Cordoba            
Sub-Investigator: Xavier Xiol            
Sub-Investigator: Monica Guevara            
Sponsors and Collaborators
Hospital Clinic of Barcelona
Maternal-Infantil Vall d´Hebron Hospital
Hospital Universitari de Bellvitge
Investigators
Principal Investigator: Pere Ginès Hospital Clinic Barcelona
  More Information

Publications:
Responsible Party: Hospital Clinic ( Pere Ginès )
Study ID Numbers: MACHT, 07/0443, 07/90077
Study First Received: February 6, 2009
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00839358     History of Changes
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
cirrhosis
renal failure
midodrine
albumine

Study placed in the following topic categories:
Liver Diseases
Renal Insufficiency
Neurotransmitter Agents
Adrenergic Agents
Hyponatremia
Liver Cirrhosis
Brain Diseases
Hemorrhage
Adrenergic Agonists
Urologic Diseases
Vasoconstrictor Agents
Midodrine
Water-Electrolyte Imbalance
Kidney Diseases
Metabolic Disorder
Hepatic Insufficiency
Liver Failure
Metabolic Diseases
Adrenergic alpha-Agonists
Central Nervous System Diseases
Cardiovascular Agents
Hepatic Encephalopathy
Sepsis
Digestive System Diseases
Peripheral Nervous System Agents
Brain Diseases, Metabolic
Kidney Failure

Additional relevant MeSH terms:
Liver Diseases
Renal Insufficiency
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Hyponatremia
Physiological Effects of Drugs
Brain Diseases
Adrenergic Agonists
Urologic Diseases
Therapeutic Uses
Vasoconstrictor Agents
Midodrine
Water-Electrolyte Imbalance
Kidney Diseases
Hepatic Insufficiency
Liver Failure
Metabolic Diseases
Adrenergic alpha-Agonists
Sympathomimetics
Nervous System Diseases
Central Nervous System Diseases
Cardiovascular Agents
Pharmacologic Actions
Hepatic Encephalopathy
Digestive System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Brain Diseases, Metabolic
Kidney Failure

ClinicalTrials.gov processed this record on May 06, 2009