1-hour Premedication for Allergy Goal in Emergency: PAGE-1 Study

Официальное название

1-hour Premedication for Allergy Goal in Emergency Computed Tomography, A Randomized Controlled Non-inferiority Trial: PAGE-1 Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое IV glucocorticoid and antihistamine
  Methylprednisolone sodium succinate (e.g., Solu-Medrol®) 40 mg IV immediately plus diphenhydramine 25 mg IV 1 hour before contrast medium administration for CT imaging
• Другое IV glucocorticoid and antihistamine (standard of care)
  Methylprednisolone sodium succinate (e.g., Solu-Medrol®) 40 mg IV immediately 4 hours before contrast medium administration, plus diphenhydramine 25 mg IV 1 hour before contrast for CT imaging

Первичные конечные точки

• Difference in proportion of Acute Contrast Reaction [Срок оценки: 30 minutes]
• Proportion of patients eligible for intervention [Срок оценки: Before randomization]

Вторичные конечные точки (2)

• Proportion randomized to intervention and control [Срок оценки: Within 30 minutes after completion of CT imaging]
• Adverse events after intervention [Срок оценки: Within 30 minutes after assessment of primary outcome]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Previous enrollment in this study
• Pregnancy
• Seafood or iodine allergy, alone
• Gadolinium allergy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Davenport MS, Cohan RH. The Evidence for and Against Corticosteroid Prophylaxis in At-Risk Patients. Radiol Clin North Am. 2017 Mar;55(2):413-421. doi: 10.1016/j.rcl.2016.10.012. PMID 28126223
• Greenberger PA, Halwig JM, Patterson R, Wallemark CB. Emergency administration of radiocontrast media in high-risk patients. J Allergy Clin Immunol. 1986 Apr;77(4):630-4. doi: 10.1016/0091-6749(86)90357-x. PMID 3958391
• Lasser EC, Berry CC, Talner LB, Santini LC, Lang EK, Gerber FH, Stolberg HO. Pretreatment with corticosteroids to alleviate reactions to intravenous contrast material. N Engl J Med. 1987 Oct 1;317(14):845-9. doi: 10.1056/NEJM198710013171401. PMID 3627208
• Katayama H, Yamaguchi K, Kozuka T, Takashima T, Seez P, Matsuura K. Adverse reactions to ionic and nonionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media. Radiology. 1990 Jun;175(3):621-8. doi: 10.1148/radiology.175.3.2343107. PMID 2343107
• Amiri E. Optimizing Premedication Strategies for Iodinated Contrast Media in CT scans: A Literature Review. J Med Imaging Radiat Sci. 2025 Jan;56(1):101782. doi: 10.1016/j.jmir.2024.101782. Epub 2024 Nov 20. PMID 39571411
• Freed KS, Leder RA, Alexander C, DeLong DM, Kliewer MA. Breakthrough adverse reactions to low-osmolar contrast media after steroid premedication. AJR Am J Roentgenol. 2001 Jun;176(6):1389-92. doi: 10.2214/ajr.176.6.1761389. PMID 11373198
• Mervak BM, Davenport MS, Ellis JH, Cohan RH. Rates of Breakthrough Reactions in Inpatients at High Risk Receiving Premedication Before Contrast-Enhanced CT. AJR Am J Roentgenol. 2015 Jul;205(1):77-84. doi: 10.2214/AJR.14.13810. PMID 26102383
• Mervak BM, Cohan RH, Ellis JH, Khalatbari S, Davenport MS. Intravenous Corticosteroid Premedication Administered 5 Hours before CT Compared with a Traditional 13-Hour Oral Regimen. Radiology. 2017 Nov;285(2):425-433. doi: 10.1148/radiol.2017170107. Epub 2017 Jul 26. PMID 28745940

Идентификаторы

NCT: NCT07268248 · Pro2025002416

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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