Infection
Conditions
Keywords
IV, Intravenous, IV Push, Piggyback, Antibiotics, Beta Lactam, Infection
Brief summary
This study compares whether or not a safety difference exists between delivering antibiotics via IV push or IV piggyback method.
Detailed description
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.
Interventions
DEVICESyringe IV Push over 2-3 minutes
IV antibiotics will be administered by Syringe IV Push over 2-3 minutes
DEVICEPiggyback over 30 minutes
IV antibiotics will be administered by IV Piggyback over 30 minutes.
Sponsors
University Medical Center of Southern Nevada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Masking description
When the pharmacist prepares the medication he/she will refer to the randomization form to select the correct study arm. The pharmacist will place a protective cover over the syringe and over the piggyback bag before it is provided to the nurse administering the medication.
Intervention model description
Single-center, prospective, double-blinded, double-dummy, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in number of adverse reactions at 90 minutes from time 0 | From the time of administration (time 0) to 90 minutes | The difference in the number of adverse reactions between the study arms within the first 90 minutes following administration of antibiotics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in severity of adverse reactions between study arms. | 90 minutes from drug administration (time 0) | 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) |
| Difference in adverse reaction type between study arms. | 90 minutes from drug administration (time 0) | 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) |
| Difference in hospital length of stay between study arms | 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. | The difference between the study arms hospital length of stay |
| Difference of In-Hospital Mortality between 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. | The difference of in-hospital mortality between the study arms. |
| Cost comparison between study arms | 90 minutes from drug administration (time 0) | A description of the cost of service between the study arms |
Countries
United States
Contacts
Primary ContactWesley J Forred, RN
Backup ContactYili Gan, MS
Outcome results
None listed