Does a Safety Difference Exist Between IV Push and IV Piggyback Antibiotics? (IVP-ABX)

November 30, 2017 updated by: Aryan Rahbar, University Medical Center of Southern Nevada

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • University Medical Center of Southen Nevada
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Syringe Arm
IV antibiotics will be delivered by syringe IV push over 2-3 minutes
Device: Syringe IV Push over 2-3 minutes
IV antibiotics will be administered by Syringe IV Push over 2-3 minutes
Other Names:
  • IVP
Sham Comparator: Piggyback Arm
IV antibiotics will be delivered by IV piggyback over 30 minutes
Device: Piggyback over 30 minutes
IV antibiotics will be administered by IV Piggyback over 30 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From the time of administration (time 0) to 90 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in severity of adverse reactions between study arms.
Time Frame: 90 minutes from drug administration (time 0)
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)
Difference in adverse reaction type between study arms.
Time Frame: 90 minutes from drug administration (time 0)
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)
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.
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.
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.
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.
Cost comparison between study arms
Time Frame: 90 minutes from drug administration (time 0)
A description of the cost of service between the study arms
90 minutes from drug administration (time 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Center of Southern Nevada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aryan Rahbar, PharmD, University Medical Center of Southern Nevada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMC-2017-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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