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

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122018
• Other study ID #: REPORT
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2005
• Last updated: November 6, 2014
• Start date: May 2002
• Est. completion date: March 2006

Study information

• Verified date: November 2014
• Source: Pulmonary Critical Care Associates of Baltimore
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Surgical Procedures
• Kidney Failure, Acute
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• N-acetylcysteine

• fenoldopam

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Linda F. Barr, M.D.	Abbott

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of post-operative hospital stay		30-day
Primary	Length of post-operative critical care stay		30-day
Primary	Creatinine clearance post-operative days 3, 14, and nadir		14 day
Secondary	Days to post-operative creatinine clearance nadir		14 day
Secondary	Intraoperative and post-operative pressor use (pressor-hours)		48 hour
Secondary	Hospital costs		30-day
Secondary	Mortality		30-day