Does a Safety Difference Exist Between IV Push and IV Piggyback Antibiotics?
Status: | Recruiting |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/6/2017 |
Start Date: | October 18, 2017 |
End Date: | December 2018 |
Contact: | Wesley J Forred, RN |
Email: | wesley.forred@umcsn.com |
Phone: | 702-466-7801 |
Safety Comparison of Antibiotics Administered Via Intravenous Push Versus Intravenous Piggyback to Adult Patients in the Emergency Department
This study compares whether or not a safety difference exists between delivering antibiotics
via IV push or IV piggyback method.
via IV push or IV piggyback method.
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.
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.
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
We found this trial at
1
site
1800 West Charleston Boulevard
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Phone: 702-224-7124
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