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Clinical Trials/NCT01587222
NCT01587222WithdrawnPhase 2

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

Anna Cruceta1 site in 1 countryStarted: July 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Withdrawn
Sponsor
Locations
1
Primary Endpoint
Glomerular filtration
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Albumin, Midodrine, Octreotide

Experimental

Intervention: Albumin (Drug)

Albumin, Midodrine, Octreotide

Experimental

Intervention: Midodrine (Drug)

Albumin, Midodrine, Octreotide

Experimental

Intervention: Octreotide (Drug)

Outcomes

Primary Outcomes

Glomerular filtration

Time Frame: 12 weeks

Change in glomerular filtration rate measured by isotopic tests

Secondary Outcomes

  • 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)

Investigators

Sponsor
Anna Cruceta
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Anna Cruceta

CTU- Clinical trial unit

Fundacion Clinic per a la Recerca Biomédica

Study Sites (1)

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