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

NCT00187330 | Completed Phase 2

• 3 other identifiers: 724180589R03-45www.psifoundation.org
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Heart Disease; Renal Insufficiency

Keywords

cardiopulmonary bypass; renal insufficiency; cardiac surgery; n-acetylcysteine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

Intravenous N-acetylcysteine DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• The Physicians' Services Incorporated Foundation: collaborator

MeSH Terms

Conditions

Heart Diseases; Renal Insufficiency

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Veena Guru, MD

  University of Toronto, Sunnybrook and Women's College Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Stephen E Fremes, MD

  Sunnybrook Health Sciences Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 2004
• Study Completion: August 1, 2005
• Last Updated: September 16, 2005

Record last verified: 2005-08