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

Phase 2

Withdrawn

• Conditions: Fibrosis; Renal Failure; Hepatorenal Syndrome
• Interventions: Drug: Albumin; Drug: Midodrine; Drug: Octreotide

• Registration Number: NCT01587222
• Lead Sponsor: Anna Cruceta

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Status Verified: 2015-09
• Study Start: 2016-07
• Primary Completion: 2017-07
• Study Completion: 2017-08
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Albumin, Midodrine, Octreotide	Albumin	-
Albumin, Midodrine, Octreotide	Midodrine	-
Albumin, Midodrine, Octreotide	Octreotide	-

Primary Outcome Measures

Name	Time	Method
Glomerular filtration	12 weeks	Change in glomerular filtration rate measured by isotopic tests

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain