1-hour Premedication for Allergy Goal in Emergency Computed Tomography, A Randomized Controlled Non-inferiority Trial: PAGE-1 Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 540
- 主要终点
- Difference in proportion of Acute Contrast Reaction
研究概览
简要总结
1-hour Premedication for Allergy Goal in Emergency: PAGE-1 is a prospective, parallel, two-arm, non-inferiority, randomized controlled trial evaluating the safety of a 1-hour (intervention) versus a 4-hour (standard regimen) intravenous (IV) premedication protocol in adult patients in the Emergency Department (ED) with a documented iodinated contrast allergy and requiring computed tomography (CT) imaging for a high-risk indication.
详细描述
Allergic or hypersensitivity reactions to iodinated contrast media are rare, estimated to occur in 0.3% to 1.4% of cases, but have decreased significantly after the switch from high-osmolar to low-osmolar contrast. Most reactions are mild, and breakthrough reactions occur regardless of the timing of premedication. IV premedication is recommended, but there is no level I evidence for its basis in the ED.
This study addresses the sparse evidence that underpins the ubiquitous multi-hour premedication protocols in EDs nationwide. It specifically challenges the existing paradigm of 4-5 hours of IV premedication, which has remarkably never been prospectively validated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 21 years old)
- •Documented iodinated contrast allergy in the electronic health record
- •CT with iodinated contrast ordered for a high-risk indication, † defined as post-arrest, concern for aortic dissection, ischemia, occlusion, obstruction, or other life-threatening conditions requiring timely diagnosis
- •Willing and able to give consent
排除标准
- •Previous enrollment in this study
- •Seafood or iodine allergy, alone
- •Gadolinium allergy
研究组 & 干预措施
1-hour Premedication Protocol
IV glucocorticoid and antihistamine 1 hour before contrast
干预措施: IV glucocorticoid and antihistamine (Other)
4-hour Premedication Protocol
IV glucocorticoid 4 hours before contrast and IV antihistamine 1 hour before contrast
干预措施: IV glucocorticoid and antihistamine (standard of care) (Other)
结局指标
主要结局
Difference in proportion of Acute Contrast Reaction
时间窗: 30 minutes
Measurement of any contrast reaction after contrast administration
Proportion of patients eligible for intervention
时间窗: Before randomization
Ratio of those eligible to screened
次要结局
- Proportion randomized to intervention and control(Within 30 minutes after completion of CT imaging)
- Adverse events after intervention(Within 30 minutes after assessment of primary outcome)
研究者
Paul Peng, MD PhD MSCR
Assistant Professor
Rutgers, The State University of New Jersey