Risk monitoring of randomized trials in emergency medicine: Experience of the Brain Resuscitation Clinical Trial II
| Autor: | Sutton-Tyrrell Kim, James V. Snyder, Norman S. Abramson, Sheryl F. Kelsey |
|---|---|
| Rok vydání: | 1991 |
| Předmět: |
medicine.medical_specialty
Resuscitation Quality Assurance Health Care Brain damage Risk monitoring Risk Assessment Professional Staff Committees law.invention Clinical Protocols Randomized controlled trial law medicine Humans Ethics Medical Intensive care medicine Decision Making Organizational Lidoflazine Coma Brain Diseases Clinical Trials as Topic business.industry Arrhythmias Cardiac General Medicine Rearrest Heart Arrest Clinical trial Research Design Brain Injuries Emergency medicine Emergency Medicine medicine.symptom business medicine.drug |
| Zdroj: | The American Journal of Emergency Medicine. 9:112-117 |
| ISSN: | 0735-6757 |
| DOI: | 10.1016/0735-6757(91)90169-k |
| Popis: | 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 arrhythmlas, 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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