Ondansetron and the QT Interval In Adult Emergency Department Patients
关键词
抽象
描述
Intravenous ondansetron is routinely used in adult emergency department patients experiencing nausea or vomiting. The FDA has changed the drug label to warn of prolongation of the QT interval and required the manufacturer to perform additional studies. There are rare case reports of cardiac electrical toxicity to include QT prolongation, atrial fibrillation, severe bradycardia, ventricular tachycardia, supraventricular tachycardia, and the potential for Torsades de Pointes. All of the reported literature on ondansetron comes from post-operative patients, patients receiving chemotherapy, and healthy volunteers, but has never been assessed in the emergency department population. Adult emergency department patients that do not meet the exclusion criteria will be enrolled prior to receiving intravenous ondansetron. Administration of ondansetron will be at the discretion of the attending physician. A twelve-lead electrocardiogram (EKG) or 12-lead rhythm strip will be generated prior to drug administration, and every 2 minutes following drug administration for 20 minutes after administration. During the entire 20 minutes the patient will be on a cardiac monitor and if any of the defined adverse cardiac electrical events occur (non-sinus rhythm, severe bradycardia, sudden cardiac death) the patient will be treated using standard Advanced Cardiac Life Support methods and admitted for continued monitoring. The mean maximal QTc prolongation (as measured by the Bazett formula), as well as the rate of adverse cardiac events with 95% confidence intervals will be reported.
The global objective of this study is to determine if routine use of intravenous ondansetron in the emergency department is associated with cardiac risks. The primary objective is to determine the mean maximal prolongation in QTc interval from baseline as measured by the Bazett formula. The secondary objective is to determine the number of severe adverse cardiac electrical events (non-sinus rhythm, severe bradycardia, sudden cardiac death) associated with routine use of intravenous ondansetron in the adult emergency department patient.
日期
| 最后验证: | 05/31/2014 |
| 首次提交: | 12/28/2012 |
| 提交的预估入学人数: | 12/28/2012 |
| 首次发布: | 01/02/2013 |
| 上次提交的更新: | 06/23/2014 |
| 最近更新发布: | 06/25/2014 |
| 首次提交结果的日期: | 05/22/2014 |
| 首次提交质量检查结果的日期: | 06/23/2014 |
| 首次发布结果的日期: | 06/25/2014 |
| 实际学习开始日期: | 11/30/2012 |
| 预计主要完成日期: | 04/30/2014 |
| 预计完成日期: | 04/30/2014 |
状况或疾病
干预/治疗
Drug: IV Ondansetron
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| IV Ondansetron Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan. | Drug: IV Ondansetron 4mg of intravenous ondansetron |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Age >18 - Patient to receive 4mg of intravenous ondansetron Exclusion Criteria: - Age <18 - known long QT syndrome - received oral or intravenous ondansetron within 4 hours of enrollment - co-administration of any known QT prolonging agents - QTc on baseline of >450 ms for males and >470ms for females - allergy or known hypersensitivity to ondansetron - altered mental status - non-sinus rhythm on baseline EKG - hypokalemia (as defined by the lower limit of normal for the reference laboratory) - hypomagnesemia (as defined by the lower limit of normal for the reference laboratory) - any presentation for chest pain with signs of ischemia on baseline EKG - QRS duration > 120 msec - bundle branch block (right or left) - ventricular pre-excitation or signs of left ventricular hypertrophy with repolarization abnormalities |
结果
主要结果指标
1. Change in QTc Interval With Ondansetron Administration [Baseline to 20 minutes]
次要成果指标
1. Number of Adverse Events [20 minutes to 8 hours]
