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

Haase, Michael, Haase-Fielitz, Anja, Bagshaw, Sean M., Reade, Michael C., Morgera, Stanislao, Seevenayagam, Siven, Matalanis, George, Buxton, Brian, Doolan, Laurie and Bellomo, Rinaldo (2007) Phase II, randomized, controlled trial of high-dose N-acetylcysteine in high-risk cardiac surgery patients. Critical Care Medicine, 35 5: 1324-1331. doi:10.1097/01.CCM.0000261887.69976.12


Author Haase, Michael
Haase-Fielitz, Anja
Bagshaw, Sean M.
Reade, Michael C.
Morgera, Stanislao
Seevenayagam, Siven
Matalanis, George
Buxton, Brian
Doolan, Laurie
Bellomo, Rinaldo
Title Phase II, randomized, controlled trial of high-dose N-acetylcysteine in high-risk cardiac surgery patients
Journal name Critical Care Medicine   Check publisher's open access policy
ISSN 0090-3493
1530-0293
Publication date 2007-05
Sub-type Article (original research)
DOI 10.1097/01.CCM.0000261887.69976.12
Open Access Status Not yet assessed
Volume 35
Issue 5
Start page 1324
End page 1331
Total pages 8
Place of publication Philadelphia, PA, United States
Publisher Lippincott Williams & Wilkins
Language eng
Formatted 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.
Keyword Acute renal dysfunction
Cardiac surgery
Cardiopulmonary bypass
N-acetylcysteine
Oxidative stress
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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