Allergic Reaction to Contrast Media, Computed Tomography, Hypersensitivity Reaction, Premedication
Conditions
Keywords
Iodinated Contrast Reaction, Contrast-enhanced CT, Glucocorticoid prophylaxis
Brief summary
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.
Detailed description
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.
Interventions
OTHERIV 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
OTHERIV 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
Sponsors
Paul Peng, MD PhD MSCR
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult (≥ 21 years old) 2. Documented iodinated contrast allergy in the electronic health record 3. 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 4. Willing and able to give consent
Exclusion criteria
1. Previous enrollment in this study 2. Pregnancy 3. Seafood or iodine allergy, alone 4. Gadolinium allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in proportion of Acute Contrast Reaction | 30 minutes | Measurement of any contrast reaction after contrast administration |
| Proportion of patients eligible for intervention | Before randomization | Ratio of those eligible to screened |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion randomized to intervention and control | Within 30 minutes after completion of CT imaging | Ratio of patients randomized to intervention and control arms, and who complete the protocol as specified |
| Adverse events after intervention | Within 30 minutes after assessment of primary outcome | Proportion of patients who required intramuscular epinephrine, noninvasive ventilation, or intubation |
Contacts
CONTACTChirag N Shah, MD
PRINCIPAL_INVESTIGATORPaul Peng
Rutgers Robert Wood Johnson Medical School
Outcome results
None listed