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Completed

NCT Number: NCT00839358

Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting 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.

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Key information

Conditions

Renal Failure Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Gastrointestinal Bleeding Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Hepatic Encephalopathy Hepatic Insufficiency Hyponatremia Infections Inflammation Kidney Diseases Liver Diseases Liver Failure Male Urogenital Diseases Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic

Villarroel 170, Barcelona, 08870, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALBUMIN

Drug

albumine 40 g every 15 days

Other names: Albumina Grifols

Midodrine

Drug

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 names: Gutron

Placebo

Drug

saline solution

Other names: Grifols saline solution

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Hospital Universitari de Bellvitge
  • Maternal-Infantil Vall d´Hebron Hospital

Registry information

Official study title

Midodrine and Albumin for Cirrhotic Patients in the Waiting List for Liver Transplantation

Acronym: MACHT

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2009
Registry last updated
Aug 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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