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临床试验/NCT03360617
NCT03360617Unknown不适用

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

University Medical Center of Southern Nevada2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2017年10月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
220
试验地点
2
主要终点
Difference in number of adverse reactions at 90 minutes from time 0

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Difference in number of adverse reactions at 90 minutes from time 0

时间窗: 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.

次要结局

  • 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.)
  • Difference in adverse reaction type between study arms.(90 minutes from drug administration (time 0))
  • Cost comparison between study arms(90 minutes from drug administration (time 0))
  • Difference in severity of adverse reactions between study arms.(90 minutes from drug administration (time 0))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aryan Rahbar

PharmD

University Medical Center of Southern Nevada

研究点 (2)

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