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Completed

NCT Number: NCT00122018

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

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.

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Key information

Conditions

Kidney Failure, Acute Acute Kidney Injury Cardiac Surgical Procedures Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

This is a randomized, double-blinded, placebo-controlled trial to evaluate fenoldopam and N-acetylcysteine (NAC) individually, and together, as renal protective agents for patients with renal insufficiency undergoing heart surgery. Subjects have chronic renal insufficiency with creatinine clearance (CrCl) </= 40cc/min but not on pre-operative dialysis, and receive: NAC 600 mg by mouth (po) twice a day (bid) or placebo starting 24 hours pre-operative and continuing through the day of surgery; and/or fenoldopam 0.1 mcg/kg/min intravenous (IV) or saline placebo at anesthetic induction and continuing for 48 hours. Outcome data include: nadir, post-operative day 3 and post-operative day 14 CrCl, time to CrCl nadir, length of Intensive Care Unit (ICU) stay, length of post-operative hospital stay, hospital costs, mortality, and the need for hemodialysis. Intraoperative and post-operative pressor use is being monitored. The enrollment will include 80 patients (20 in each group).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

N-acetylcysteine

Drug

Other names: Mucomyst

Fenoldopam

Drug

Other names: Corlopam

Primary outcomes

  1. Length of post-operative hospital stay

    Time frame: 30-day

  2. Length of post-operative critical care stay

    Time frame: 30-day

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

    Time frame: 14 day

Secondary outcomes

  1. Days to post-operative creatinine clearance nadir

    Time frame: 14 day

  2. Intraoperative and post-operative pressor use (pressor-hours)

    Time frame: 48 hour

  3. Hospital costs

    Time frame: 30-day

  4. Mortality

    Time frame: 30-day

Sponsors and collaborators

Lead sponsor

Linda F. Barr, M.D.

Other

Collaborators

  • Abbott

Registry information

Official study title

N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery.

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Jul 21, 2005
Registry last updated
Nov 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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