title: Risk monitoring of randomized trials in emergency medicine: experience of the Brain Resuscitation Clinical Trial II.
abstract: Risk monitoring for the Brain Resuscitation Clinical Trial II, a multicenter, placebo-controlled trial to evaluate the efficacy of the calcium-entry blocker lidoflazine in the amelioration of brain damage in comatose cardiac-arrest survivors, posed unexpected challenges. Concern arose when monitoring of adverse reactions showed an excess of dangerous cardiac arrhythmias, including rearrest, in the lidoflazine group. To ascertain the cause of this problem and determine whether it was ethical for the trial to continue, an in-depth review of data was conducted, outside experts were consulted, and additional data were collected. These efforts suggested possible causes for the problem. Existing drug administration protocols for blood pressure control were reinforced, resulting in lower subsequent arrhythmia rates. Thus, through an efficient monitoring system, an important problem was uncovered and resolved, allowing the trial to be completed without major changes.
authors.affiliation: Department of Epidemiology, University of Pittsburgh, PA 15261.
authors.forename: K
authors.initials: K
authors.lastname: Sutton-Tyrrell
authors.forename: J V
authors.initials: JV
authors.lastname: Snyder
authors.forename: S
authors.initials: S
authors.lastname: Kelsey
authors.forename: N
authors.initials: N
authors.lastname: Abramson
mesh_terms: D001145:Arrhythmias, Cardiac / Q000139:chemically induced* / Q000453:epidemiology / Q000401:mortality; D001927:Brain Diseases; D001930:Brain Injuries / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D002985:Clinical Protocols / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D003659:Decision Making, Organizational; D004992:Ethics, Medical; D006323:Heart Arrest / Q000150:complications*; D006801:Humans; D008013:Lidoflazine / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D011367:Professional Staff Committees / Q000458:organization & administration; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D012107:Research Design / Q000592:standards; D012151:Resuscitation / Q000379:methods / Q000592:standards; D018570:Risk Assessment
chemical_list: D008013:Lidoflazine