None listed
Conditions
Brief summary
This study aims to evaluate a new method, the IRIS protocol, for administering drug provocation tests to patients with suspected drug allergies during surgery. The IRIS protocol gradually increases the drug dosage more slowly than the standard method, potentially reducing the risk of severe allergic reactions. We hypothesize that the IRIS protocol will result in lower drug doses at the time a reaction is detected, making it a safer alternative to current practices.
Interventions
IRIS Protocol (Intervention Group):
Overview: The IRIS (Infusion Rate Increasing System) protocol is an innovative approach designed to reduce the total dose administered at the time a hypersensitivity reaction is recognized. This protocol uses a non-linear, exponentially increasing infusion rate, which gradually introduces the drug at a slower rate initially and accelerates as the infusion progresses.
Dose: Patients in this group will also receive 10% of the therapeutic dose of the drug being
IRIS Protocol (Intervention Group): Overview: The IRIS (Infusion Rate Increasing System) protocol is an innovative approach designed to reduce the total dose administered at the time a hypersensitivity reaction is recognized. This protocol uses a non-linear, exponentially increasing infusion rate, which gradually introduces the drug at a slower rate initially and accelerates as the infusion progresses. Dose: Patients in this group will also receive 10% of the therapeutic dose of the drug being tested. Infusion Rate and Duration: The 10% dose will be administered over the same period of 22 minutes, but the infusion rate will start slowly and increase exponentially as the infusion progresses. The initial rate is much lower than in the constant infusion method, with the rate increasing progressively over the 22-minute period. Rationale: The IRIS protocol is designed to align with the log-normal distribution of hypersensitivity thresholds observed in the population. By starting with a very low infusion rate, the protocol aims to detect hypersensitivity reactions at lower doses. This method seeks to minimize the amount of drug delivered during the latency period (the time between reaching the reaction threshold and the onset of symptoms). IRIS is used to administer the drug provocation challenge, as a non-linear intravenous infusion of 10% of the therapeutic dose of the suspected allergen (most commonly cephazolin or a neuromuscular blocking agent) in 50mL of solution over 22 minutes. The protocol will be administered by a non-blinded researcher, but the patient and staff monitoring the patient and collecting data will be blinded.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Adult Patients: Participants must be adults (18 years and older). Referral for Drug Provocation Testing: Patients must be referred for drug provocation testing (DPT) due to suspected perioperative drug hypersensitivity. Negative or Inconclusive Prior Diagnostic Tests: Participants should have undergone prior diagnostic tests (such as skin tests or basophil activation tests) that have returned negative or inconclusive results, indicating the need for further testing through DPT. Capacity to Consent: Participants must be able to provide informed consent, understanding the nature and potential risks of the study.
Exclusion criteria
Key Exclusion Criteria: Known Hypersensitivity to Tested Drug: Patients with a confirmed hypersensitivity or allergy to the specific drug being tested will be excluded, as the study focuses on those with suspected false-negative results. Severe Comorbidities: Participants with severe comorbid conditions (such as uncontrolled cardiovascular disease, severe asthma, or other conditions that could increase the risk of participating in the study) will be excluded to ensure patient safety. Pregnancy or Breastfeeding: Pregnant or breastfeeding women will be excluded from the study due to the potential risks to the fetus or infant. Recent Anaphylaxis: Patients who have experienced a recent anaphylactic reaction (within the last 6 weeks) may be excluded to prevent potential complications related to residual sensitivity. Inability to Comply with Study Protocol: Patients who are unable to comply with the study protocol, including follow-up visits and procedures, will be excluded to ensure the integrity of the study data.
Outcome results
None listed