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Intra-Renal Therapy of Diuretic Unresponsive Acute Kidney Injury

NCT01073189 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-03-28

No results posted yet for this study

Summary

Randomized prospective trial of patients with diuretic unresponsive acute kidney injury where patients will receive standard supportive therapy with diuretics versus intra-renal delivery of the vasodilator fenoldopam mesylate.

Patients with rising creatinine who fail to respond to bolus diuretics will be treated with a prolonged course of diuretics or undergo placement of a catheter within the renal arteries that allows for infusion of fenoldopam mesylate. The rational is that early delivery of a high dose vasodilator may reverse the decline of renal function in patients with severe acute kidney injury.

Conditions

  • Kidney Failures, Acute

Interventions

DRUG

Intra-Renal Fenoldopam

Placement of an intra-renal catheter for infusion of fenoldopam mesylate

DRUG

Furosemide

Patients randomized to the Diuretic Control group will receive intravenous furosemide as an active control

Sponsors & Collaborators

  • Southeast Renal Research Institute

    lead OTHER

Principal Investigators

  • James A Tumlin, MD · Southeast Renal Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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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 NCT01073189 on ClinicalTrials.gov