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An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery

NCT00122018 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-11-07

No results posted yet for this study

Summary

Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.

Conditions

  • Kidney Failure, Acute
  • Kidney Failure, Chronic
  • Cardiac Surgical Procedures

Interventions

DRUG

N-acetylcysteine

DRUG

fenoldopam

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Linda F. Barr, M.D.

    lead OTHER

Principal Investigators

  • Linda F Barr, MD · Pulmonary and Critical Care Assoc. of Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2006-03-31
Completion
2006-03-31

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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 NCT00122018 on ClinicalTrials.gov