NCT00122018

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2002

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

November 7, 2014

Status Verified

November 1, 2014

Enrollment Period

3.8 years

First QC Date

July 14, 2005

Last Update Submit

November 6, 2014

Conditions

Kidney Failure, AcuteKidney Failure, ChronicCardiac Surgical Procedures

Keywords

Kidney failureCardiac SurgeryFenoldopamN-acetylcysteine

Outcome Measures

Primary Outcomes (3)

  • Length of post-operative hospital stay

    30-day

  • Length of post-operative critical care stay

    30-day

  • Creatinine clearance post-operative days 3, 14, and nadir

    14 day

Secondary Outcomes (4)

  • Days to post-operative creatinine clearance nadir

    14 day

  • Intraoperative and post-operative pressor use (pressor-hours)

    48 hour

  • Hospital costs

    30-day

  • Mortality

    30-day

Study Arms (4)

NAC

EXPERIMENTAL

N-acetylcysteine started day prior to surgery, continued through night of surgery

Drug: N-acetylcysteine

fenoldopam

EXPERIMENTAL

fenoldopam started at surgery continued for 24 hours

Drug: fenoldopam

NAC and fenoldopam

EXPERIMENTAL

Both N-acetylcysteine and fenoldopam as above

Drug: N-acetylcysteineDrug: fenoldopam

Control

PLACEBO COMPARATOR

Placebo

Interventions

N-acetylcysteineDRUG
Also known as: Mucomyst
NACNAC and fenoldopam
fenoldopamDRUG
Also known as: Corlopam
NAC and fenoldopamfenoldopam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic creatinine clearance \</= 40cc/h
  • Pre-operative cardiac surgery

You may not qualify if:

  • Pre-operative ongoing dialysis
  • Nausea and vomiting
  • Uncontrolled glaucoma
  • Allergy to metabisulfite
  • Enrollment in another clinical study within 30 days
  • Pregnancy
  • Acute renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Barr LF, Kolodner K. N-acetylcysteine and fenoldopam protect the renal function of patients with chronic renal insufficiency undergoing cardiac surgery. Crit Care Med. 2008 May;36(5):1427-35. doi: 10.1097/CCM.0b013e31816f48ba.

    PMID: 18434903RESULT

  • Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.

    PMID: 39607014DERIVED

MeSH Terms

Conditions

Acute Kidney InjuryKidney Failure, ChronicRenal Insufficiency

Interventions

AcetylcysteineFenoldopam

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Linda F Barr, MD

    Pulmonary and Critical Care Assoc. of Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

July 14, 2005

First Posted

July 21, 2005

Study Start

May 1, 2002

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

November 7, 2014

Record last verified: 2014-11