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Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.

This study has suspended participant recruitment.
(opposite result)
Synmosa Biopharma Corp.
Information provided by:
Far Eastern Memorial Hospital Identifier:
First received: September 11, 2005
Last updated: February 6, 2009
Last verified: June 2006
The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.

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

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Far Eastern Memorial Hospital:

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

Estimated Enrollment: 60
Study Start Date: January 2005
Estimated Study Completion Date: June 2007
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.


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
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Please refer to this study by its identifier: 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
  More Information Identifier: NCT00190034     History of Changes
Other Study ID Numbers: FEMH-93010
Study First Received: September 11, 2005
Last Updated: February 6, 2009

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
Antidotes processed this record on September 21, 2017