Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.

This study has suspended participant recruitment.
(opposite result)
Sponsor:
Collaborator:
SYNMOSA BIOPHARMA
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00190034
First received: September 11, 2005
Last updated: February 6, 2009
Last verified: June 2006
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00190034

Locations
Taiwan
Far Eastern Memorial Hospital
Pan-Chiao, Taipei, Taiwan, 220
Sponsors and Collaborators
Far Eastern Memorial Hospital
SYNMOSA BIOPHARMA
Investigators
Study Chair: Shao-jung Li, M.D. Far Eastern Memorial Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00190034     History of Changes
Other Study ID Numbers: FEMH-93010, FEMH-93-C-030
Study First Received: September 11, 2005
Last Updated: February 6, 2009
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on October 02, 2014