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

Infection Clinical Trial

— IVP-ABX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03360617
• Other study ID #: UMC-2017-100
• Status: Recruiting
• Phase: N/A
• First received: November 6, 2017
• Last updated: November 30, 2017
• Start date: October 18, 2017
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: University Medical Center of Southern Nevada
• Contact: Wesley J Forred, RN
• Phone: 702-466-7801
• Email: wesley.forred[@]umcsn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection

Intervention

Device:
• Syringe IV Push over 2-3 minutes
IV antibiotics will be administered by Syringe IV Push over 2-3 minutes
• Piggyback over 30 minutes
IV antibiotics will be administered by IV Piggyback over 30 minutes.

Locations

Country	Name	City	State
United States	University Medical Center of Southen Nevada	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center of Southern Nevada

Country where clinical trial is conducted

United States, 

References & Publications (10)

Butterfield-Cowper JM, Burgner K. Effects of i.v. push administration on ß-lactam pharmacodynamics. Am J Health Syst Pharm. 2017 May 1;74(9):e170-e175. doi: 10.2146/ajhp150883. — View Citation

Garrelts JC, Smith DF, Ast D, Peterie JD. A comparison of the safety, timing and cost-effectiveness of administering antibiotics by intravenous bolus (push) versus intravenous piggyback (slow infusion) in surgical prophylaxis. Pharmacoeconomics. 1992 Feb; — View Citation

Garrelts JC, Wagner DJ. The pharmacokinetics, safety, and tolerance of cefepime administered as an intravenous bolus or as a rapid infusion. Ann Pharmacother. 1999 Dec;33(12):1258-61. — View Citation

Institute for Safe Medication Practices (ISMP, 2015). Safe Practice guidelines for Adult IV Push Medications. Retrieved from http://www.ismp.org/Tools/guidelines/ivsummitpush/ivpushmedguidelines.pdf

Martz C, Hoesly M, Davis N. Reducing Order to Antibiotic Administration Time in Septic Patients: The Role of IV Push Antibiotics. Unpublished Abstract. Eastern Virginia Medical School Institutional Review Board.

Norrby SR, Newell PA, Faulkner KL, Lesky W. Safety profile of meropenem: international clinical experience based on the first 3125 patients treated with meropenem. J Antimicrob Chemother. 1995 Jul;36 Suppl A:207-23. — View Citation

Poole SM, Nowobilski-Vasilios A, Free F. Intravenous push medications in the home. J Intraven Nurs. 1999 Jul-Aug;22(4):209-15. — View Citation

Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima — View Citation

Sanborn M, Gabay M, Moody ML. The Safety of Intravenous Drug Delivery Systems: Update on Current Issues Since the 1999 Consensus Development Conference. Hospital Pharmacy 2009.44(2):159-164

Wiskirchen DE, Housman ST, Quintiliani R, Nicolau DP, Kuti JL. Comparative pharmacokinetics, pharmacodynamics, and tolerability of ertapenem 1 gram/day administered as a rapid 5-minute infusion versus the standard 30-minute infusion in healthy adult volunteers. Pharmacotherapy. 2013 Mar;33(3):266-74. doi: 10.1002/phar.1197. Epub 2013 Feb 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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.
Secondary	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.
Secondary	Cost comparison between study arms	A description of the cost of service between the study arms	90 minutes from drug administration (time 0)