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

Renal Failure Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01587222
• Other study ID #: MAFRI-II
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: August 2017

Study information

• Verified date: September 2015
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Hepatorenal Syndrome
• Renal Failure
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Anna Cruceta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular filtration	Change in glomerular filtration rate measured by isotopic tests	12 weeks
Secondary	Changes in plasma renin activity, plasma aldosterone and norepinephrine		4, 12 and 16 weeks
Secondary	Changes in blood pressure measured by Holter		4, 12 and 16 weeks
Secondary	Changes in renal function		at 4 weeks after cessation of treatment