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

NCT01587222 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-02-15

No results posted yet for this study

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).

Conditions

  • Fibrosis
  • Renal Failure
  • Hepatorenal Syndrome

Interventions

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.

Sponsors & Collaborators

  • Anna Cruceta

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-07-31
Completion
2017-08-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01587222 on ClinicalTrials.gov