MedTrace Logo

Vasodilators and Anti-Oxidant Therapy in Early ATN

NCT00286403 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2016-03-28

No results posted yet for this study

Summary

Patients developing kidney failure after open heart surgery experience an abrupt decrease in blood flow to the kidney. The investigators hypothesize that administration of fenoldopam mesylate (a drug that increases blood flow to the kidney) to patients early in the course of their disease could reduce progression to dialysis-dependent acute renal failure. The investigators also hypothesize that restoring blood flow could induce additional injury to the kidney through the release of reactive oxygen species. Therefore, patients in this protocol will be randomized to receive a fenoldopam or the anti-oxidant MESNA. The investigators hypothesize that combination treatment with Fenoldopam and MESNA will decrease the incidence of death or dialysis at 21 days in patients with early post-operative acute renal failure.

Conditions

  • Acute Renal Failure

Interventions

DRUG

Fenoldopam Mesylate and/or MESNA

Sponsors & Collaborators

  • Dialysis Clinic, Inc.

    collaborator INDUSTRY

  • Southeast Renal Research Institute

    lead OTHER

Principal Investigators

  • James A Tumlin, MD · Southeast Renal Research Institute

  • Micheal Kutner, Ph.D. · Rollins School Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00286403 on ClinicalTrials.gov