Jan Grendar1, Jean F Ouellet2, Andrew McKay3, Francis R Sutherland4, Oliver F Bathe4, Chad G Ball4, Elijah Dixon4. 1. Providence Portland Medical Center, Portland, Oregon. 2. CHU-Pavillon Hopital de l'Enfant-Jesus, Quebec City, Quebec, Canada. 3. Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada. 4. Division of General Surgery, University of Calgary, Calgary, Alberta, Canada.
Abstract
BACKGROUND AND OBJECTIVES: Liver failure following hepatic resection is a multifactorial complication. In experimental studies, infusion of N-acetylcysteine (NAC) can minimize hepatic parenchymal injury. METHODS:Patients undergoing liver resection were randomized to postoperative care with or without NAC. No blinding was performed. Overall complication rate was the primary outcome; liver failure, length of stay, and mortality were secondary outcomes. Due to safety concerns, a premature multivariate analysis was performed and included within the model randomization to NAC, preoperative ASA, extent of resection, and intraoperative vascular occlusion as factors. RESULTS:Two hundred and six patients were randomized (110 to conventional therapy; 96 to NAC). No significant differences were noted in overall complications (32.7% and 45.7%, P = 0.06) or hepatic failure (3.6% and 5.4%, P = 0.537) between treatment groups. There was significantly more delirium within the NAC group (2.7% and 9.8%, P < 0.05) that caused early trial termination. In multivariate analysis, only randomization to NAC (OR = 2.21, 95%CI = 1.16-4.19) and extensive resections (OR = 2.28, 95%CI = 1.22-4.29) were predictive of postoperative complications. CONCLUSIONS: Patients randomized to postoperative NAC received no benefit. There was a trend toward a higher rate of overall complications and a significantly higher rate of delirium in the NAC group. J. Surg. Oncol. 2016;114:446-450.
RCT Entities:
BACKGROUND AND OBJECTIVES:Liver failure following hepatic resection is a multifactorial complication. In experimental studies, infusion of N-acetylcysteine (NAC) can minimize hepatic parenchymal injury. METHODS:Patients undergoing liver resection were randomized to postoperative care with or without NAC. No blinding was performed. Overall complication rate was the primary outcome; liver failure, length of stay, and mortality were secondary outcomes. Due to safety concerns, a premature multivariate analysis was performed and included within the model randomization to NAC, preoperative ASA, extent of resection, and intraoperative vascular occlusion as factors. RESULTS: Two hundred and six patients were randomized (110 to conventional therapy; 96 to NAC). No significant differences were noted in overall complications (32.7% and 45.7%, P = 0.06) or hepatic failure (3.6% and 5.4%, P = 0.537) between treatment groups. There was significantly more delirium within the NAC group (2.7% and 9.8%, P < 0.05) that caused early trial termination. In multivariate analysis, only randomization to NAC (OR = 2.21, 95%CI = 1.16-4.19) and extensive resections (OR = 2.28, 95%CI = 1.22-4.29) were predictive of postoperative complications. CONCLUSIONS:Patients randomized to postoperative NAC received no benefit. There was a trend toward a higher rate of overall complications and a significantly higher rate of delirium in the NAC group. J. Surg. Oncol. 2016;114:446-450.
Authors: Christopher G Hughes; Christina S Boncyk; Deborah J Culley; Lee A Fleisher; Jacqueline M Leung; David L McDonagh; Tong J Gan; Matthew D McEvoy; Timothy E Miller Journal: Anesth Analg Date: 2020-06 Impact factor: 5.108