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临床试验/NCT05139628
NCT05139628Unknown不适用

The Impact of Skin Colonization at the Peripheral Venous Catheter Insertion Sites on Catheter Tip Colonization and Catheter Related Blood Stream Infections Among Pediatric Oncology Patients.

Assiut University0 个研究点目标入组 100 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Study the impact of Peripheral intravenous catheter skin colonization on catheter tip colonization and the development of Catheter related blood stream infections in pediatric oncology patients and Identify the associated risk factors.

研究概览

简要总结

The aim of this work is to:

  1. Study the impact of PIVC skin colonization on catheter tip colonization and the development of CRBSI
  2. isolate and identify the organisms causing peripheral venous catheter related blood stream infections in pediatric oncology patients.
  3. perform antimicrobial sensitivity testing of isolated organisms.
  4. identify the associated risk factors that lead to CRBSIs in such group of patients.

详细描述

Peripheral intravenous catheters (PIVCs) are small flexible tubes that are vital for the delivery of therapies, such as fluids, drugs, and blood transfusions that are required in up to 70% of hospitalized patients. The PIVC is introduced through the skin into the peripheral veins of the arms, hands, or lower limbs. Despite their relatively short-term use (typically <1 week) they are a potential source of catheter-related bloodstream infections (CRBSIs) implicated in up to 5% of nosocomial bacteremias, with a prevalence of 0.67%-2.4 %. Such infections increase a patient's risk of death, discomfort, and length of hospital stay.

Among pediatric patients with hemato-oncologic disease, intravascular catheter-associated bloodstream infection is the most common cause of bloodstream infections leading to increased mortality and morbidity in such patients. The Mortality rates of bloodstream infections in patients with malignancy are significantly higher than in patients without malignancy. There is a paucity of data on blood stream infections (BSIs) generally amongst paediatric oncology patients in low and middle-income countries, and especially CRBSIs.

Cancer patients are predisposed to BSI for several reasons:

  • Alterations in anatomic barriers, both internal and external leading to enhance access of bacteria and fungi to the bloodstream.
  • Changes in both cell-mediated and humoral immunity occur related both to the primary tumor and the subsequent treatment.
  • Infectious complications in pediatric hematology-oncology patients have been significantly associated with the presence of indwelling catheters.

With most clinical studies focusing on central vascular catheters, infections associated with short peripheral venous catheters have received little attention. While central line-associated bloodstream infections have become an important metric in assessing patient safety, peripheral intravenous catheters (PVCs) remain underappreciated as an intravascular device that is also responsible for catheter-associated bloodstream infections.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The following data will be collected for each patient :
  • Type of malignancy
  • PIVC location
  • Antimicrobial use
  • Parenteral nutrition
  • Dwell-time
  • The reason for removal (eg, treatment complete, PIVC complications, or suspected infection, or routinely (72-96 hours).
  • Exclusion criteria:
  • Patient with existing bloodstream infections.
  • or those with any type of infections

排除标准

  • 未提供

结局指标

主要结局

Study the impact of Peripheral intravenous catheter skin colonization on catheter tip colonization and the development of Catheter related blood stream infections in pediatric oncology patients and Identify the associated risk factors.

时间窗: 1 year (Anticipated)

Isolate and identify the organisms causing CRBSIs and perform antimicrobial sensitivity testing of the isolated organisms.

次要结局

未报告次要终点

研究者

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

Mariam Mohamed Abdel-Hafeez

Assistant Lecturer

Assiut University

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