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

Sponsor
Anna Cruceta (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01587222
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
13
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Anticipated Study Start Date :
Jul 1, 2016
Anticipated Primary Completion Date :
Jul 1, 2017
Anticipated Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Glomerular filtration [12 weeks]

    Change in glomerular filtration rate measured by isotopic tests

Secondary Outcome Measures

  1. Changes in plasma renin activity, plasma aldosterone and norepinephrine [4, 12 and 16 weeks]

  2. Changes in blood pressure measured by Holter [4, 12 and 16 weeks]

  3. Changes in renal function [at 4 weeks after cessation of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hospital Clinic i Provincial de Barcelona Barcelona Spain 08036

Sponsors and Collaborators

  • Anna Cruceta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anna Cruceta, CTU- Clinical trial unit, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier:
NCT01587222
Other Study ID Numbers:
  • MAFRI-II
First Posted:
Apr 30, 2012
Last Update Posted:
Feb 15, 2019
Last Verified:
Sep 1, 2015
Additional relevant MeSH terms:
Hepatorenal Syndrome
Renal Insufficiency
Octreotide
Midodrine

Study Results

No Results Posted as of Feb 15, 2019