Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cardiovascular Disease Renal Insufficiency, Acute Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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N-Acetylcysteine 600mg/tab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No