Does a Safety Difference Exist Between IV Push and IV Piggyback Antibiotics?

Study Overview
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Brief Summary
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This study compares whether or not a safety difference exists between delivering antibiotics via IV push or IV piggyback method.

Detailed Description
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This study compares whether or not a safety difference exists between delivering antibiotics via the IV push or IV piggyback method. It will be a single center, prospective, double-blinded, double-dummy, randomized controlled trial on a convenience sample of patients presenting to the ED receiving select beta-lactam antibiotics. Patients will be randomized to IV push antibiotic plus IV piggyback placebo or IV push placebo plus IV piggyback antibiotic. Patients will only be enrolled when a pharmacist who is familiar with the study is available to prepare medications. Treatment group assignment will be predetermined using an Excel random number generator. An investigator will conduct an informed consent with the patient. Only the pharmacist will have access to the randomization records and will not reveal the randomization until the end of the study. If the patient consents to the study, a pharmacist involved in the study will prepare the IV push syringe and IV piggyback. The IV push syringe and IV piggyback will be prepared in a manner that makes the contents blinded. Preparation of the IV push syringe and IV piggyback are standardized. The syringe and piggyback will be handed to the nurse for administration. The IV push antibiotic will be administered over 2-3 minutes and the IV piggyback antibiotic will be administered over 30 minutes. The IV push and IV piggyback will be administered at the same time. A research assistant will conduct surveys with the patient at the start of administration and every 15 minutes for a total of 90 minutes to observe for any adverse drug reactions. During the 90-minute observation period, other medications will be allowed to be administered to the patient. All medications received during this time period will be documented in the patient data sheet. If an adverse drug reaction occurs, the attending physician or medical resident caring for the patient will be notified to come evaluate the patient. Adverse drug reaction severity will be determined by the attending physician or medical resident based on a predetermined scale. Adverse drug reaction information will be collected to determine correlation of adverse drug reaction to drug administration. Adverse drug reactions deemed as serious will be reported to the Institutional Review Board (IRB) within 5 days of the event.

Official Title
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Safety Comparison of Antibiotics Administered Via Intravenous Push Versus Intravenous Piggyback to Adult Patients in the Emergency Department

Conditions
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Infection

Intervention / Treatment
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* Device: Syringe IV Push over 2-3 minutes
* Device: Piggyback over 30 minutes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Patients who present to the adult ED in whom IV aztreonam, cefazolin, cefoxitin, ceftriaxone, cefepime, ertapenem, or meropenem is ordered by the treating physician Exclusion Criteria: Pregnant or breastfeeding Non-English speaking patient Attending provider excludes patient Unable to consent Prisoner Allergy to any beta-lactam antibiotic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center, prospective, double-blinded, double-dummy, randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Syringe Arm<br>IV antibiotics will be delivered by syringe IV push over 2-3 minutes | Device: Syringe IV Push over 2-3 minutes<br>* IV antibiotics will be administered by Syringe IV Push over 2-3 minutes<br>* Other names: IVP;|
| Sham Comparator: Piggyback Arm<br>IV antibiotics will be delivered by IV piggyback over 30 minutes | Device: Piggyback over 30 minutes<br>* IV antibiotics will be administered by IV Piggyback over 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in number of adverse reactions at 90 minutes from time 0 | The difference in the number of adverse reactions between the study arms within the first 90 minutes following administration of antibiotics. | From the time of administration (time 0) to 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in severity of adverse reactions between study arms. | The difference in severity of adverse reaction between the study arms based on the National Cancer Institute's, Common Terminology Criteria for Adverse Events, v4.0 (2017) | 90 minutes from drug administration (time 0) | 
| Difference in adverse reaction type between study arms. | The difference between the study arms for type of adverse reactions based on the National Cancer Institute's, Common Terminology Criteria for Adverse Events, v4.0 (2017) | 90 minutes from drug administration (time 0) | 
| Difference in hospital length of stay between study arms | The difference between the study arms hospital length of stay | Time from subject's arrival to Emergency Department (ED) until either discharged from ED to home, or if admitted, hospital discharge up to 90 days from ED admission. | 
| Difference of In-Hospital Mortality between study arms | The difference of in-hospital mortality between the study arms. | Time from the subject's arrival to the Emergency Department (ED) until the subject is pronounced dead up to 90 days from ED admission. | 
| Cost comparison between study arms | A description of the cost of service between the study arms | 90 minutes from drug administration (time 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV, Intravenous, IV Push, Piggyback, Antibiotics, Beta Lactam, Infection