Phase II, randomized, controlled trial of high-dose N-acetylcysteine in high-risk cardiac surgery patients

Michael Haase, Anja Haase-Fielitz, Sean M. Bagshaw, Michael C. Reade, Stanislao Morgera, Siven Seevenayagam, George Matalanis, Brian Buxton, Laurie Doolan, Rinaldo Bellomo

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Abstract

OBJECTIVE: To assess the effect of high-dose N-acetylcysteine on renal function in cardiac surgery patients at higher risk of postoperative renal failure. DESIGN: Multiblind, placebo-controlled, randomized, phase II clinical trial. SETTING: Operating rooms and intensive care units of two tertiary referral hospitals. PATIENTS: A total of 60 cardiac surgery patients at higher risk of postoperative renal failure. INTERVENTIONS: Patients were allocated to either 24 hrs of high-dose N-acetylcysteine infusion (300 mg/kg body weight in 5% glucose, 1.7 L) or placebo (5% glucose, 1.7 L). MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was the absolute change in serum creatinine from baseline to peak value within the first five postoperative days. Secondary outcomes included the relative change in serum creatinine, peak serum creatinine level, serum cystatin C, and in urinary output. Further outcomes were needed for renal replacement therapy, length of ventilation, and length of stay in the intensive care unit and hospital. Randomization was successful and patients were well balanced for preoperative and intraoperative characteristics. There was no significant attenuation in the increase in serum creatinine from baseline to peak when comparing N-acetylcysteine with placebo (64.5 ± 91.2 and 38.0 ± 42.4 μmol/L, respectively; p = .15). Also, there was no attenuation in the increase in serum cystatin C from baseline to peak for N-acetylcysteine compared with placebo (0.45 ± 0.43 and 0.30 ± 0.33 mg/L, respectively; p = .40). Likewise, there was no evidence for differences in any other clinical outcome. CONCLUSIONS: In this phase II, randomized, controlled trial, high-dose N-acetylcysteine was no more effective than placebo in attenuating cardiopulmonary bypass-related acute renal failure in high-risk cardiac surgery patients.

Original languageEnglish
Pages (from-to)1324-1331
Number of pages8
JournalCritical Care Medicine
Volume35
Issue number5
DOIs
Publication statusPublished - 1 Jan 2007

Keywords

  • Acute renal dysfunction
  • Cardiac surgery
  • Cardiopulmonary bypass
  • N-acetylcysteine
  • Oxidative stress

Cite this

Haase, M., Haase-Fielitz, A., Bagshaw, S. M., Reade, M. C., Morgera, S., Seevenayagam, S., Matalanis, G., Buxton, B., Doolan, L., & Bellomo, R. (2007). Phase II, randomized, controlled trial of high-dose N-acetylcysteine in high-risk cardiac surgery patients. Critical Care Medicine, 35(5), 1324-1331. https://doi.org/10.1097/01.CCM.0000261887.69976.12