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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Fibrosis Renal Failure Hepatorenal Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Albumin, Midodrine, Octreotide

Group Type EXPERIMENTAL

Albumin

Intervention Type DRUG

Albumin (20%) 1g/kg iv on day 1 and 80 g every 2 weeks during a period of 12 weeks.

Midodrine

Intervention Type DRUG

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.

Octreotide

Intervention Type DRUG

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.

Interventions

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Albumin

Albumin (20%) 1g/kg iv on day 1 and 80 g every 2 weeks during a period of 12 weeks.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No