A Study of The Effectiveness of N-Acetylcysteine in Kidney Protection Following Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00187330
First received: September 9, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
  Purpose

N-acetylcysteine is a medication that has most commonly been used in the past to prevent liver damage after an acetaminophen overdose. N-acetylcysteine has also been used in patients with pre-existing kidney damage to prevent further kidney damage resulting from dye that is used in tests such as angiograms (dye studies). This study hopes to prove that this medication may also help to protect kidneys from the damage caused by the heart-lung machine during cardiac surgery. This damage to the kidneys happens to patients undergoing cardiac surgery requiring the use of the heart-lung machine. Kidney failure after surgery is a serious complication (2-30% of patients with kidney problems can develop it) and it can lead to short term and long-term dialysis as well as death (there is up to a 30% death rate once kidney failure develops). The study will test if intravenous N-acetylcysteine is safe and effective in preventing kidney problems after cardiac surgery using the heart-lung machine. Approximately 104 patients will be enrolled at Sunnybrook and Women’s College Health Science Centre. The study has been reviewed and approved by the ethics committee at Sunnybrook and Women’s College Health Science Centre. The study will compare the effects of N-acetylcysteine with those of placebo (salt solution). The study medication (either N-acetylcysteine or placebo) will be given in addition to your usual medication and surgical procedures.


Condition Intervention Phase
Heart Disease
Renal Insufficiency
Drug: Intravenous N-acetylcysteine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Randomized Placebo Controlled Trial of Intravenous N-Acetylcysteine (NAC) As A Renal Protective Agent for Prevention of Renal Dysfunction Following Cardiopulmonary Bypass (CPB)

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • The change in serum creatinine between NAC and placebo groups from preoperative baseline levels to peak postoperative levels after exposure to CPB.

Secondary Outcome Measures:
  • Include change in GFR, BUN and troponin; early dialysis; in-hospital mortality; postop MI; stroke; and postop LOS. SNPs related to renal insufficiency, ischemia, and inflammation will be analyzed in relation to serum inflammatory markers.

Estimated Enrollment: 104
Study Start Date: March 2004
Estimated Study Completion Date: August 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The study includes those patients with preoperative renal dysfunction (serum creatinine level 140 μmol/L or greater or a calculated glomerular filtration rate of 50 mL/min or less), or a risk factor score for postoperative renal dysfunction that adds up to 6 or more based on the following scale:

Score Risk Factor:

  • 3 scheduled for redo cardiac surgery
  • 3 scheduled for valve surgery
  • 2 age greater than 69 at time of surgery
  • 2 known diabetic (Type I or II)
  • 2 congestive heart failure
  • 2 treated hypertension
  • 2 chronic obstructive pulmonary disease
  • 2 preoperative stroke
  • 1 left ventricular function –grade 3 or 4 (seen on echo or angiogram)
  • 1 New York Heart Association Class 3 or 4

Exclusion Criteria:

  • Patient is participating in another trial
  • Patient has received NAC in the past 48 hours.
  • Patient has allergy to N-acetylcysteine.
  • Patient scheduled for off-pump surgery or an extracardiac procedure (pericardiectomy etc.)
  • Patient requires emergent surgery
  • Patient scheduled for a procedure involving circulatory arrest.
  • Patient requires chronic dialysis (peritoneal or hemodialysis)
  • Patient unable to give informed consent (dementia, does not speak English, etc.)
  • Patient has a recent history of cancer (in last five years) or untreated cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187330

Sponsors and Collaborators
Sunnybrook Health Sciences Centre
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Veena Guru, MD University of Toronto, Sunnybrook and Women's College Health Sciences Centre
Study Chair: Stephen E Fremes, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00187330     History of Changes
Other Study ID Numbers: 724180589, R03-45, www.psifoundation.org
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
cardiopulmonary bypass
renal insufficiency
cardiac surgery
n-acetylcysteine

Additional relevant MeSH terms:
Heart Diseases
Renal Insufficiency
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Protective Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on August 20, 2014