Clinical trial NCT00122018: An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery
Official title: N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Failure, Acute
Kidney Failure, Chronic
Cardiac Surgical Procedures
Keywords: Kidney failure
Cardiac Surgery
Fenoldopam
N-acetylcysteine
Lead sponsor: Pulmonary Critical Care Associates of Baltimore
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2005-07-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Length of post-operative hospital stay
timeFrame: 30-day
measure: Length of post-operative critical care stay
timeFrame: 30-day
measure: Creatinine clearance post-operative days 3, 14, and nadir
timeFrame: 14 day
Secondary outcomes:
measure: Days to post-operative creatinine clearance nadir
timeFrame: 14 day
measure: Intraoperative and post-operative pressor use (pressor-hours)
timeFrame: 48 hour
measure: Hospital costs
timeFrame: 30-day
measure: Mortality
timeFrame: 30-day
Other outcomes:
Locations:
Study officials:
affiliation: Pulmonary and Critical Care Assoc. of Baltimore
name: Linda F Barr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.