Skip to content

Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.

N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.

Status
Suspended
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00190034
Enrollment
60
Registered
2005-09-19
Start date
2005-01-31
Completion date
2007-06-30
Last updated
2009-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Bypass, Cardiovascular Disease, Renal Insufficiency, Acute

Keywords

Acetylcysteine, cardiac surgery, cardiopulmonary bypass, acute renal insufficiency

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.

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.

Interventions

Sponsors

Synmosa Biopharma Corp.
CollaboratorINDUSTRY
Far Eastern Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026