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

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).

Study Overview

• Status: Withdrawn
• Conditions: Fibrosis; Renal Failure; Hepatorenal Syndrome
• Intervention / Treatment: Drug: Albumin; Drug: Midodrine; Drug: Octreotide

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glomerular filtration	Change in glomerular filtration rate measured by isotopic tests	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Anna Cruceta

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: April 27, 2012
• First Submitted That Met QC Criteria: April 27, 2012
• First Posted (Estimate): April 30, 2012

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Kidney Diseases; Urologic Diseases; Liver Diseases; Renal Insufficiency; Hepatorenal Syndrome; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Adrenergic alpha-1 Receptor Agonists; Octreotide; Midodrine
• Other Study ID Numbers: MAFRI-II