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Mechanism and the Effect of Midodrine on Portal Pressures in Patients With Cirrhosis

NCT01331785 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-07-31

No results posted yet for this study

Summary

Ascites is a frequent complication of patients with portal hypertension. As portal hypertension progresses, a percentage of these patients develop refractory ascites. Management options at that point include either TIPS or intermittent large volume paracentesis (LVP), with its attendant risks, Portal hypertension is accompanied by systemic circulatory dysfunction (decreased systemic vascular resistance and systolic BP), which is exacerbated by large volume paracentesis, with resultant renal and cardiac dysfunction. There are limited options for managing patients with acute decompensation, such as hepatorenal syndrome, although midodrine and other vasoconstrictors have been used in such patients. Midodrine has not been used as a possible therapeutic for ascites. Midodrine however, has been found to change the hemodynamics related to portal hypertension and ascites. There has been also change in mediators related to renal and circulation in studies of short duration (7 days) but not found in studies of 1 month duration, however the clinical effects of midodrine is found for longer duration in other similar conditions.

The purpose of the study is to assess the utility of midodrine in patients with obvious systemic circulatory dysfunction (hypotension) in improving the outcome of patients with refractory ascites and change in hemodynamic parameters and its mediators.

Specific endpoints include:

1\) an objective reduction of the volume/rate of accumulation of ascites and 2) a decrease in the frequency of LVP.

Conditions

  • Cirrhosis
  • End Stage Liver Disease
  • Ascites
  • Hypotension

Interventions

DRUG

Midodrine

Midodrine 2.5 mg to 10 mg three times a day to increase systolic BP above 100 mmHgor by 10 mmHg

Sponsors & Collaborators

  • American College of Gastroenterology

    collaborator OTHER

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Achuthan Sourianarayanane · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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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 NCT01331785 on ClinicalTrials.gov