5-HT3 Antagonists (Antiemetics) and Cardiac Safety Using an Active Surveillance Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Identify clinical and genetic variants associated with ondansetron-induced prolongation of QT interval
研究概览
简要总结
5-HT3 antagonists (ondansetron) are highly effective medications for the treatment of nausea and vomiting. However, these medications also associated with potentially severe and life-threatening cardiac adverse drug reactions (ADRs), particularly QT prolongation. Data regarding the cardiac safety and inter-individual variability in cardiac effects of ondansetron when used in vulnerable populations such as children and pregnant women are very limited. The results of this study will enable better-informed therapeutic decision-making regarding the use of ondansetron in children and pregnant women, with the overall goal to improve the safety of these commonly used antiemetic medications. Furthermore, predictive pharmacogenetic markers of severe 5-HT3 antagonist toxicity could be used to identify patients at risk of cardiac toxicity before the drug is administered.
详细描述
The specific objectives are to:
- Determine and compare the cardiac safety profile of ondansetron in children, when used for prevention and management of post-operative nausea and vomiting and chemotherapy induced nausea and vomiting. Identify clinical factors including pre-existing cardiac conditions or physiological conditions that predispose to ventricular arrhythmias, concomitant cardiotoxic chemotherapy or concomitant volatile anaesthetic agents and investigate their impact on cardiac adverse effects of ondansetron.
- Determine and compare the cardiac safety profile of ondansetron when used in pregnant women or women of a reproductive age for the treatment of hyperemesis gravidarum or post-operative nausea and vomiting. Identify clinical factors including pre-existing cardiac conditions or physiological conditions, which predispose to ventricular arrhythmias that may support implementation of risk mitigation actions.
- Identify genetic variants associated with 5-HT3 antagonist-induced prolongation of QT interval.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 6 months - 18 years of age who are being treated with ondansetron for prevention and management of post-operative nausea and vomiting and chemotherapy-induced nausea and vomiting.
- •Pregnant women and women of a reproductive age (18-45 years of age) who are being treated with ondansetron for hyperemesis gravidarum or postoperative nausea and vomiting.
排除标准
- •Patients with congenital long QT syndrome.
- •Subjects who do not speak and understand English.
研究组 & 干预措施
Pediatric patients
Children <6 months to 18 years of age receiving ondansetron for management of:
- Post-operative nausea and vomiting
- Chemotherapy-induced nausea and vomiting
干预措施: Ondansetron (Drug)
Female patients
Pregnant patients or women of a reproductive age (18-45 years) receiving ondansetron for management of:
- Hyperemesis gravidarum
- Post-operative nausea and vomiting
干预措施: Ondansetron (Drug)
结局指标
主要结局
Identify clinical and genetic variants associated with ondansetron-induced prolongation of QT interval
时间窗: Up to 2 years
次要结局
未报告次要终点
研究者
Bruce Carleton
Director, Pharmaceutical Outcomes Programme
University of British Columbia