![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
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 |
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 |
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 |
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
|
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:
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pere Gines, MD | 0034932275753 | pgines@clinic.ub.es |
Contact: Monica Guevara, MD | 0034932275753 | mguevara@clinic.ub.es |
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 |
Principal Investigator: | Pere Ginès | Hospital Clinic Barcelona |
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 |
cirrhosis renal failure midodrine albumine |
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 |
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 |