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

NCT ID: NCT03360617

Last Updated: 2017-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-18

Study Completion Date

2018-12-31

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.

Conditions

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Infection

Keywords

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IV Intravenous IV Push Piggyback Antibiotics Beta Lactam Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center, prospective, double-blinded, double-dummy, randomized controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

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Syringe Arm

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

Group Type EXPERIMENTAL

Syringe IV Push over 2-3 minutes

Intervention Type DEVICE

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

Piggyback Arm

IV antibiotics will be delivered by IV piggyback over 30 minutes

Group Type SHAM_COMPARATOR

Piggyback over 30 minutes

Intervention Type DEVICE

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

Interventions

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Syringe IV Push over 2-3 minutes

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

Intervention Type DEVICE

Piggyback over 30 minutes

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

Intervention Type DEVICE

Other Intervention Names

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IVP

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center of Southern Nevada

OTHER

Sponsor Role lead

Responsible Party

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Aryan Rahbar

PharmD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aryan Rahbar, PharmD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center of Southern Nevada

Locations

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University Medical Center of Southen Nevada

Las Vegas, Nevada, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Wesley J Forred, RN

Role: CONTACT

Phone: 702-466-7801

Email: [email protected]

Yili Gan, MS

Role: CONTACT

Phone: 702-383-7336

Email: [email protected]

Facility Contacts

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Wesley J Forred, RN

Role: primary

Yili Gan, MA

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 10630824 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23400916 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10476138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28438821 (View on PubMed)

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.

Reference Type 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

Reference Type 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.

Reference Type RESULT
PMID: 30559529 (View on PubMed)

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.

Reference Type RESULT
PMID: 28098591 (View on PubMed)

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.

Reference Type RESULT
PMID: 10172048 (View on PubMed)

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.

Reference Type RESULT
PMID: 8543496 (View on PubMed)

Other Identifiers

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UMC-2017-100

Identifier Type: -

Identifier Source: org_study_id