Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190034
Recruitment Status : Suspended (opposite result)
First Posted : September 19, 2005
Last Update Posted : February 9, 2009
Synmosa Biopharma Corp.
Information provided by:
Far Eastern Memorial Hospital

Brief Summary:
The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Renal Insufficiency, Acute Cardiopulmonary Bypass Drug: N-Acetylcysteine 600mg/tab Phase 4

Detailed Description:

BACKGROUND Reactive oxygen species have been shown to cause contrast-induced nephrotoxicity (CIN). According to previous studies, the N-acetylcysteine has been proved to be advantageous in the avoidance of CIN. We seek to evaluate the efficacy of the antioxidant N-acetylcysteine in limiting the nephrotoxicity after cardiovascular surgery with cardiopulmonary bypass.

METHODS We will prospectively study 60 patients who will receive a cardiovascular surgery with cardiopulmonary bypass. Patients will be randomly assigned to receive either N-acetylcysteine (600 mg orally twice daily for 4 doses) with 0.45% saline intravenously, before and after cardiopulmonary bypass, or placebo with 0.45% saline. Serum creatinine and blood urea nitrogen will be measured before, 48 h and 5 days after the operation procedure.

Expected results Prophylactic oral administration of the antioxidant N-acetylcysteine, along with hydration, will significantly reduce the acute renal damage induced by CPB in patients with chronic renal insufficiency that need cardiovascular procedures.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.
Study Start Date : January 2005
Estimated Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients who will received cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  1. Dialyzed patients
  2. Acute renal failure
  3. Advanced left ventricular systolic dysfunction defined as left ventricular ejection fraction ≦ 35%.
  4. Acute chronic obstructive lung disease or asthma exacerbation
  5. Allergy to N-acetylcysteine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00190034

Far Eastern Memorial Hospital
Pan-Chiao, Taipei, Taiwan, 220
Sponsors and Collaborators
Far Eastern Memorial Hospital
Synmosa Biopharma Corp.
Study Chair: Shao-jung Li, M.D. Far Eastern Memorial Hospital Identifier: NCT00190034     History of Changes
Other Study ID Numbers: FEMH-93010
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: June 2006

Keywords provided by Far Eastern Memorial Hospital:
cardiac surgery
cardiopulmonary bypass
acute renal insufficiency

Additional relevant MeSH terms:
Cardiovascular Diseases
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs