Antiemetic Fosaprepitant To Remedy Nausea and Vomiting
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Sustained Relief from NV
研究概览
简要总结
The study team proposes a randomized, double-blind, RCT to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time. The outcome for the efficacy analysis will be no need for additional medication to treat nausea and vomiting within 2 hours of investigational medication administration. The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration.
详细描述
Nausea and vomiting (NV) are common and interrelated conditions. Approximately 50% of adults experience nausea in a given year while 30% of adults experience vomiting over the same period. Of this population of symptomatic individuals with NV, 25% of patients seek care in any healthcare delivery setting. Health Care Utilization Project (HCUP) data indicates that nearly 9.0 million patients seek care for NV in emergency departments (EDs) each year in the United States.
Antiemetics are used to treat NV. Antiemetics currently utilized in the emergency department setting for NV do not always work on the first dose and have a plethora of side effects because of their peripheral mechanism of action outside of the vomiting reflex pathway in the central nervous system. These medications include ondansetron, promethazine, metoclopramide, olanzapine, haloperidol. Chief among these side effects is alteration of an aspect cardiac electrical signaling called the QT segment which represents the duration of ventricular contraction and relaxation. The QT segment is prolonged with commonly used antiemetics which can often be a prelude to cardiac dysrhythmias that are associated with mortality. As a result, patients with NV often have long length-of-stay (LOS) involving supportive care with intravenous fluids or empiric treatment with medications that can potentiate development of cardiac dysrhythmias. This is a problem in busy emergency departments (EDs) struggling to accelerate patient throughput in order to appropriately keep up with patient volume in an under-supplied hospital bed environment nationally.
Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults at least 18 years old
- •Present to an emergency department (ED) for nausea and/or vomiting as defined by the International Classification of Diseases (ICD-10), or identified by treating clinician
- •Following the approval of a protocol amendment, study patients who have received an antiemetic and remain persistently nauseated after 2 hours will be eligible to participate in the study
排除标准
- •Pregnancy, desiring pregnancy, or lactating
- •Antiemetic medication use less than 2 hours prior to screening
- •Bradycardia (heart rate less than 60 bpm heart rate)
- •Prolonged QTc (>480ms)
- •Not conversant in English or Spanish
- •Altered mental status
- •Lack of phone for follow-up communication
研究组 & 干预措施
Investigational Intervention
Fosaprepitant 150mg IV administered over 15 minutes
干预措施: Fosaprepitant 150 mg (Drug)
Standard-of-Care Intervention
Ondansetron 4mg IV administered over 15 minutes
干预措施: Ondansetron 4 mg (Drug)
结局指标
主要结局
Sustained Relief from NV
时间窗: 24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours)
Sustained relief from nausea and vomiting will be determined by the intensity of nausea reported by participants following administration of antiemetic. Intensity of nausea will be reported as either None, Mild, Moderate, or Severe. The number/percentage of participants reporting each degree of nausea intensity will be summarized Sustained relief of nausea and vomiting requires a patient to present with a nausea intensity of either "severe" or "moderate," which is then reduced by treatment to at least "mild" or "none," within two hours of medication administration, and then maintained at "mild" or "none" level for the entire 24-hour period following medication administration without the use of rescue medication.
次要结局
- Severity of Nausea(24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours))
- Need for rescue antiemetic medication(2 hours (assessed at the 2 hour mark after administration of the intervention))
- Medication Preference(24 hours)
- Functional disability(24 hours (assessed prior to receiving intervention, at 2 hour point after receiving intervention, and 24 hours after intervention))
- Vomiting(24 hours)
- Hospitalization(24 hours)
- Fluid Treatment(4 hours)
- QTc Interval (QT interval corrected for heart rate)(Prior to Intervention and at disposition, approximately 2 hours)
- Revisit Rate(24 hours)
- Mean Fluid Volume(4 hours)
- Length of Stay(Initial presentation to disposition, approximately 4 hours)