InfectionIVP-ABXNCT03360617
Does a Safety Difference Exist Between IV Push and IV Piggyback Antibiotics?
A study testing Syringe IV Push over 2-3 minutes and Piggyback over 30 minutes in people with Infection, run by University Medical Center of Southern Nevada at 1 site in United States.
Trial summary
This study compares whether or not a safety difference exists between delivering antibiotics via IV push or IV piggyback method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Syringe IV Push over 2-3 minutes and Piggyback over 30 minutes
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding
- Non-English speaking patient
- Attending provider excludes patient
- Unable to consent
- Prisoner
- Allergy to any beta-lactam antibiotic
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Medical Center of Southen Nevada
Las Vegas, Nevada, 89102
Wesley J Forred, RN, 702-224-7124, wesley.forred@umcsn.com
Yili Gan, MA, 702-383-7336, yili.gan@umcsn.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Infection
- Being tested
- Syringe IV Push over 2-3 minutes, Piggyback over 30 minutes
- Keywords
- IV, Intravenous, IV Push, Piggyback, Antibiotics, Beta Lactam, Infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syringe IV Push over 2-3 minutesDevice
Also called IVP
IV antibiotics will be administered by Syringe IV Push over 2-3 minutes
Piggyback over 30 minutesDevice
IV antibiotics will be administered by IV Piggyback over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Syringe Arm | Experimental | IV antibiotics will be delivered by syringe IV push over 2-3 minutes Receives: Device: Syringe IV Push over 2-3 minutes |
| Piggyback Arm | Sham comparator | IV antibiotics will be delivered by IV piggyback over 30 minutes Receives: Device: Piggyback over 30 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the time of administration (time 0) to 90 minutes
Secondary outcomes (5)
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)
Measured: 90 minutes from drug administration (time 0)
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)
Measured: 90 minutes from drug administration (time 0)
Difference in hospital length of stay between study arms
The difference between the study arms hospital length of stay
Measured: 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
The difference of in-hospital mortality between the study arms.
Measured: 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
A description of the cost of service between the study arms
Measured: 90 minutes from drug administration (time 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start18 Oct 2017
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, double-blinded, double-dummy, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center of Southern Nevada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aryan Rahbar, University Medical Center of Southern Nevada
- Investigators
- Aryan Rahbar, PharmD, Principal investigator, University Medical Center of Southern Nevada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360617
- Sponsor's protocol ID
- UMC-2017-100
- Acronym
- IVP-ABX
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 10630824Wiskirchen 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.
PubMed 23400916Poole SM, Nowobilski-Vasilios A, Free F. Intravenous push medications in the home. J Intraven Nurs. 1999 Jul-Aug;22(4):209-15.
PubMed 10476138Butterfield-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.
PubMed 28438821Martz 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.
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
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.
PubMed 30559529Rhodes 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.
PubMed 28098591Garrelts 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.
PubMed 10172048Norrby 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.
PubMed 8543496
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Comparison of Antibiotics Administered Via Intravenous Push Versus Intravenous Piggyback to Adult Patients in the Emergency Department
- ClinicalTrials.gov ID
- NCT03360617
- Acronym / sponsor ID
- IVP-ABX / UMC-2017-100
- Conditions
- Infection
- Keywords
- IV, Intravenous, IV Push, Piggyback, Antibiotics, Beta Lactam, Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Medical Center of Southern NevadaUniversity, hospital or other
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Single-center, prospective, double-blinded, double-dummy, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Syringe Arm | Experimental | Device: Syringe IV Push over 2-3 minutesIV antibiotics will be delivered by syringe IV push over 2-3 minutes |
| Piggyback Arm | Sham comparator | Device: Piggyback over 30 minutesIV antibiotics will be delivered by IV piggyback over 30 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding
- Non-English speaking patient
- Attending provider excludes patient
- Unable to consent
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syringe IV Push over 2-3 minutesAlso: IVPIV antibiotics will be administered by Syringe IV Push over 2-3 minutes | Device | Syringe Arm |
| Piggyback over 30 minutesIV antibiotics will be administered by IV Piggyback over 30 minutes. | Device | Piggyback Arm |
Primary outcome
Difference in number of adverse reactions at 90 minutes from time 0
Time frame: 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.
5 secondary outcomes
Difference in severity of adverse reactions between study arms.
Time frame: 90 minutes from drug administration (time 0)
Difference in adverse reaction type between study arms.
Time frame: 90 minutes from drug administration (time 0)
Difference in hospital length of stay between study arms
Time frame: 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 frame: 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
Time frame: 90 minutes from drug administration (time 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Background: PubMed 10630824Garrelts 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.
- Background: PubMed 23400916Wiskirchen 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.
- Background: PubMed 10476138Poole SM, Nowobilski-Vasilios A, Free F. Intravenous push medications in the home. J Intraven Nurs. 1999 Jul-Aug;22(4):209-15.
- Background: PubMed 28438821Butterfield-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.
- BackgroundMartz 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.
- Results publicationInstitute 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
- Results publication: PubMed 30559529Rodriguez 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.
- Results publication: PubMed 28098591Rhodes 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.
- Results publication: PubMed 10172048Garrelts 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.
- Results publication: PubMed 8543496Norrby 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aryan Rahbar, PharmD principal investigator
University Medical Center of Southern Nevada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syringe IV Push over 2-3 minutes and Piggyback over 30 minutes in people with Infection, run by University Medical Center of Southern Nevada at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wesley J Forred, RN (702-466-7801, wesley.forred@umcsn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in number of adverse reactions at 90 minutes from time 0 (time frame: From the time of administration (time 0) to 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360617, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2017.