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Midodrine, Octreotide and Albumin: Impact on Renal Function of Patients With Liver Cirrhosis and Renal Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Anna Cruceta, Fundació Clínic per la Recerca Biomèdica.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01587222
First Posted: April 30, 2012
Last Update Posted: September 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anna Cruceta, Fundació Clínic per la Recerca Biomèdica
  Purpose
The aim of this study is to evaluate the treatment with midodrine, octreotide and albumin during 12 weeks in patients with hepatorenal syndrome. Fifteen patients will be enrolled and followed during 16 weeks. The effects on renal function will be evaluated 12 and 16 weeks after the beginning of the treatment by isotopic evidence and biochemist determinations. Also it will be evaluated arterial pressure and determination of vasoactive hormones (plasma renin, aldosterone and norepinephrine).

Condition Intervention Phase
Fibrosis Renal Failure Hepatorenal Syndrome Drug: Albumin Drug: Midodrine Drug: Octreotide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Anna Cruceta, Fundació Clínic per la Recerca Biomèdica:

Primary Outcome Measures:
  • Glomerular filtration [ Time Frame: 12 weeks ]
    Change in glomerular filtration rate measured by isotopic tests


Secondary Outcome Measures:
  • Changes in plasma renin activity, plasma aldosterone and norepinephrine [ Time Frame: 4, 12 and 16 weeks ]
  • Changes in blood pressure measured by Holter [ Time Frame: 4, 12 and 16 weeks ]
  • Changes in renal function [ Time Frame: at 4 weeks after cessation of treatment ]

Estimated Enrollment: 15
Study Start Date: July 2013
Estimated Study Completion Date: August 2016
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albumin, Midodrine, Octreotide Drug: Albumin
Albumin (20%) 1g/kg iv on day 1 and 80 g every 2 weeks during a period of 12 weeks.
Drug: Midodrine

Oral midodrine 5 mg / 8 hours for 12 weeks. The dose may be increased on day 7 10mg/8h.

If creatinine does not decrease ≥ 25% and systolic blood pressure is bellow 150 mmHg and diastolic 90 mmHg doses will be changed.

Drug: Octreotide

Octreotide by subcutaneous injection 0.1 mg every 8 hours for 12 weeks. The dose may be increased to 0.2 mg / 8 h on day 7.

If creatinine does not decrease ≥ 25% and systolic blood pressure is bellow 150 mmHg and diastolic 90 mmHg doses will be changed.


  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 80 years
  • Cirrhosis of the liver defined by clinical, biochemical or histological
  • Functional renal failure with serum creatinine greater than 1.2 mg / dl and less than 2.5 mg / dl.
  • That, properly informed, give their consent to participate in the study and undergo tests and examinations that entails
  • Women of childbearing potential: pregnancy test negative serum or urine, and acceptance of use of adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last dose

Exclusion Criteria:

  • Pregnant women, nursing mothers, or those who intend to become pregnant during the study period
  • Systolic blood pressure ≥ 150 mmHg and / or diastolic blood pressure ≥ 90 mmHg
  • Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical portosystemic shunts
  • Use of antibiotics in the seven days prior to inclusion in the study except for prophylactic (ie. prophylaxis of spontaneous bacterial peritonitis)
  • Cardiac or respiratory failure
  • Positive for human immunodeficiency virus
  • Urinary retention
  • Ischemic heart disease or peripheral vascular disease.
  • Narrow Angle Glaucoma
  • Cerebrovascular occlusions
  • Aortic Aneurysm
  • Thyrotoxicosis
  • Pheochromocytoma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587222


Contacts
Contact: Pere Ginès Gibert, MD pgines@clinic.ub.es

Locations
Spain
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Pere Gines, MD       PGINES@clinic.ub.es   
Sponsors and Collaborators
Anna Cruceta
  More Information

Responsible Party: Anna Cruceta, CTU- Clinical trial unit, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier: NCT01587222     History of Changes
Other Study ID Numbers: MAFRI-II
First Submitted: April 27, 2012
First Posted: April 30, 2012
Last Update Posted: September 11, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Renal Insufficiency
Hepatorenal Syndrome
Kidney Diseases
Urologic Diseases
Liver Diseases
Digestive System Diseases
Octreotide
Midodrine
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action