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

NCT03360617 | Unknown FDA Device

• 1 other identifier: UMC-2017-100
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infection

Keywords

IV; Intravenous; IV Push; Piggyback; Antibiotics; Beta Lactam; Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Difference in severity of adverse reactions between study arms.

  90 minutes from drug administration (time 0)

• Difference in adverse reaction type between study arms.

  90 minutes from drug administration (time 0)

• 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.

• 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.

• Cost comparison between study arms

  90 minutes from drug administration (time 0)

Study Arms (2)

Syringe Arm

EXPERIMENTAL

IV antibiotics will be delivered by syringe IV push over 2-3 minutes

Device: Syringe IV Push over 2-3 minutes

Piggyback Arm

SHAM COMPARATOR

IV antibiotics will be delivered by IV piggyback over 30 minutes

Device: Piggyback over 30 minutes

Interventions

Syringe IV Push over 2-3 minutes DEVICE

IV antibiotics will be administered by Syringe IV Push over 2-3 minutes

Also known as: IVP

Syringe Arm

Piggyback over 30 minutes DEVICE

IV antibiotics will be administered by IV Piggyback over 30 minutes.

Piggyback Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding
• Non-English speaking patient
• Attending provider excludes patient
• Unable to consent
• Prisoner
• Allergy to any beta-lactam antibiotic

Sponsors & Collaborators

• University Medical Center of Southern Nevada: lead

Study Sites (1)

University Medical Center of Southen Nevada

Las Vegas, Nevada, 89102, United States

RECRUITING

Related Publications (10)

• 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. doi: 10.1345/aph.19067.

  PMID: 10630824 BACKGROUND

• 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.

  PMID: 23400916 BACKGROUND

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

  PMID: 10476138 BACKGROUND

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

  PMID: 28438821 BACKGROUND

• 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.

  BACKGROUND

• 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

  RESULT

• Rodriguez R. The Safety of Intravenous Drug Delivery Systems: Update on Current Issues Since the 2009 Consensus Development Conference. Hosp Pharm. 2018 Dec;53(6):408-414. doi: 10.1177/0018578718798638. Epub 2018 Sep 5.

  PMID: 30559529 RESULT

• 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 S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.

  PMID: 28098591 RESULT

• 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;1(2):116-23. doi: 10.2165/00019053-199201020-00008.

  PMID: 10172048 RESULT

• 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. doi: 10.1093/jac/36.suppl_a.207.

  PMID: 8543496 RESULT

MeSH Terms

Conditions

Infections

Study Officials

• Aryan Rahbar, PharmD

  University Medical Center of Southern Nevada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wesley J Forred, RN

CONTACT

702-466-7801; wesley.forred@umcsn.com

Yili Gan, MS

CONTACT

702-383-7336; yili.gan@umcsn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD

Model Details: Single-center, prospective, double-blinded, double-dummy, randomized controlled trial

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: December 4, 2017
• Study Start: October 18, 2017
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 4, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)