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

Primary Purpose

Fibrosis, Renal Failure, Hepatorenal Syndrome

Status
Withdrawn
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Albumin
Midodrine
Octreotide
Sponsored by
Anna Cruceta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinic i Provincial de Barcelona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Albumin, Midodrine, Octreotide

Arm Description

Outcomes

Primary Outcome Measures

Glomerular filtration
Change in glomerular filtration rate measured by isotopic tests

Secondary Outcome Measures

Changes in plasma renin activity, plasma aldosterone and norepinephrine
Changes in blood pressure measured by Holter
Changes in renal function

Full Information

First Posted
April 27, 2012
Last Updated
February 13, 2019
Sponsor
Anna Cruceta
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1. Study Identification

Unique Protocol Identification Number
NCT01587222
Brief Title
Midodrine, Octreotide and Albumin: Impact on Renal Function of Patients With Liver Cirrhosis and Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
the sponsor did not provide the treatment
Study Start Date
July 2016 (Anticipated)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Cruceta

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosis, Renal Failure, Hepatorenal Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albumin, Midodrine, Octreotide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Albumin
Intervention Description
Albumin (20%) 1g/kg iv on day 1 and 80 g every 2 weeks during a period of 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Midodrine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Octreotide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glomerular filtration
Description
Change in glomerular filtration rate measured by isotopic tests
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in plasma renin activity, plasma aldosterone and norepinephrine
Time Frame
4, 12 and 16 weeks
Title
Changes in blood pressure measured by Holter
Time Frame
4, 12 and 16 weeks
Title
Changes in renal function
Time Frame
at 4 weeks after cessation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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