Peripheral Venous Catheter Related Blood Stream Infections

February 28, 2022 updated by: Mariam Mohamed Abdel-Hafeez, Assiut University

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Catheter related bloodstream infection (CRBSI) is defined as the presence of bacteremia originating from an intravenous catheter. An estimated 60% of these CRBSIs are associated with the patient's skin flora.The skin is a complex environment that provides greater space for diverse commensal and pathogenic microbes. Catheter colonization occurs by progression of microorganisms to the tip of the catheter along either the inner surface (≥7 days of indwelling time) or the outer surface (<7 days of indwelling time) of the catheter. Even despite skin site decontamination with antiseptic prior to PIVC insertion, bacteria may remain in the hair follicles and lower dermis, and immediately after post insertion catheter, the bacteria begin proliferation. If conditions are particularly favorable, for example moisture from diaphoresis, blood ooze, and numerous hair follicles, bacterial growth becomes faster. Skin bacteria can progressively colonize down the insertion site along the PIVC tract. However, the impact of PIVC skin site colonization on tip colonization and the development of CRBSI has never been investigated comprehensively.

Study Type

Observational

Enrollment (Anticipated)

100

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

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

Ages Eligible for Study

3 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

• This study will be conducted on pediatric patients admitted to South Egypt Cancer Institute -Assiut University with more than 48hrs of catheter insertion.Patients ( age > 40 days up to 18 years) from both sexes.

Description

Inclusion Criteria:

  • The following data will be collected for each patient :
  • Age
  • Sex
  • 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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 year (Anticipated)
Isolate and identify the organisms causing CRBSIs and perform antimicrobial sensitivity testing of the isolated organisms.
1 year (Anticipated)

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Nahla M Elsherbiny, Prof. Dr., Professor of Medical Microbiology and Immunology Faculty of Medicine - Assiut University
  • Study Director: Mona H Abdel-Rahim, A. prof., Assistant professor of Medical Microbiology and Immunology

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 (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVC related BSIs

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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