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Title: The Australasian Clinical Toxicology Investigators Collaboration randomized trial of different loading infusion rates of N-acetylcysteine.
Austin Authors: Kerr, Fergus;Dawson, Andrew;Whyte, Ian M;Buckley, Nicholas A;Murray, Lindsay;Graudins, Andis ;Chan, Betty;Trudinger, Barbara
Affiliation: Austin Health, Heidelberg, Victoria, Australia
Issue Date: 1-Apr-2005
Publication information: Annals of Emergency Medicine; 45(4): 402-8
Abstract: We determine whether the incidence of adverse events caused by intravenous N -acetylcysteine is significantly less when the initial dose is infused over a 60-minute period compared with the standard infusion period of 15 minutes. A secondary objective is to assess the efficacy of the 2 treatment arms.This was a multicenter, randomized, prospective trial of patients who presented with acetaminophen poisoning and who were treated with N -acetylcysteine and had no history of hypersensitivity to N-acetylcysteine. Patients were randomly assigned to receive the initial dose of N-acetylcysteine over a 15-minute or 60-minute period. Baseline signs and symptoms and adverse events were serially evaluated before and during administration of N -acetylcysteine. Tests of liver injury and coagulation were collected at baseline and then at 12-hour intervals.The study was designed with an 80% power to detect a halving of the incidence of adverse events. Of 180 evaluable patients, 109 patients were randomized to the 15-minute group and 71 patients were randomized to the 60-minute group. The incidence of drug-related adverse events was 45% in the 15-minute group and 38% in the 60-minute group (95% confidence interval -8% to 22%). The study did not demonstrate a reduction of drug-related adverse outcomes with the 60-minute infusion. Incidence of maximum alanine aminotransferase levels indicating hepatotoxicity (serum level >1,000 IU/L) was 6.8% (5.6% for 15-minute, 8.7% for 60-minute). The difference did not attain statistical significance.This study did not demonstrate a reduction of drug-related adverse outcomes with the 60-minute infusion. The study also confirmed that early treatment with N -acetylcysteine (within 8 hours of ingestion) is more effective than later treatment.
Gov't Doc #: 15795719
DOI: 10.1016/j.annemergmed.2004.08.040
Journal: Annals of emergency medicine
Type: Journal Article
Subjects: Acetaminophen.blood.poisoning
Acetylcysteine.administration & dosage.adverse effects
Alanine Transaminase.blood
Anaphylaxis.chemically induced
Aspartate Aminotransferases.blood
Drug Administration Schedule
Drug-Induced Liver Injury
Infusions, Intravenous
International Normalized Ratio
Liver Diseases.diagnosis.prevention & control
Nausea.chemically induced
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