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Central Venous Catheter-Related Infection

Primary Purpose

Critically Ill Patients, Infection

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Antimicrobial impregnated catheter (5593)
Sponsored by
University of Witwatersrand, South Africa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critically Ill Patients focused on measuring Central venous catheters, Antimicrobial impregnated catheters, Duration of catheter use, Catheter-related infection, Insertion site, Parenteral nutrition, Critically ill patients (multidisciplinary)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • critically ill patients likely to require central venous catheter for at least 14 days
  • age 18+ years
  • white cell count on admission > 4 x 10 to 9/L
  • absence of skin burns
  • no history of allergy to sulfa containing preparations
  • consent obtained
  • catheter to be inserted via internal jugular or subclavian veins

Exclusion Criteria:

  • age < 18 years
  • white blood cell count on admission of less than 4 x 10 to 9/L
  • skin burns
  • history of allergy to sulfa-containing preparations
  • guidewire changes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    5592

    5593

    Arm Description

    Standard triple lumen catheter

    Antimicrobial impregnated catheter (chlorhexidine silver-sulfadiazine)

    Outcomes

    Primary Outcome Measures

    To determine the influence of antimicrobial impregnated catheters on the incidence of catheter-related infection and whether CVCs can safely be left in place for a period of up to 14 days in critically ill patients

    Secondary Outcome Measures

    To elucidate the epidemiology and risks of catheter-related infection in a population of critically ill patients

    Full Information

    First Posted
    September 21, 2007
    Last Updated
    September 28, 2007
    Sponsor
    University of Witwatersrand, South Africa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00533988
    Brief Title
    Central Venous Catheter-Related Infection
    Official Title
    Central Venous Catheter-Related Infection: A Prospective Randomized Double-Blind Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 1999 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Witwatersrand, South Africa

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Intravascular devices are an integral component of modern-day medical practice. Infection is one of the leading complications of intravascular catheters and is associated with an increased mortality, prolonged hospitalization and increased medical costs. Central venous catheters (CVCs) account for an estimated 90% of all catheter-related bloodstream infections (CRBSI). A host of risk factors for CVC-related infections have been documented. This includes most importantly, duration of catheterization. The duration of use of CVCs remains controversial and the length of time such devices can safely be left in situ has not been fully and objectively addressed in the critically ill patient. As a consequence, scheduled replacement remains widely practiced in many Intensive Care Units(ICUs). Over the past few years, antimicrobial impregnated catheters have been introduced in an attempt to limit catheter-related infection (CRI) and increase the time that CVCs can safely be left in place. Recent meta-analyses concluded that antimicrobial impregnated CVCs appear to be effective in reducing CRI. The topic however, remains extremely controversial with different viewpoints appearing in the literature recently. This was a prospective randomized double-blind study performed in the multidisciplinary ICU at Johannesburg Hospital over a four year period.The study entailed a comparison of standard triple-lumen versus antimicrobial impregnated CVCs on the rate of CRI. The aim was to determine whether the researchers could safely increase the duration of catheter insertion time from the standard practice of seven days to 14 days, to assess the influence of the antimicrobial impregnated catheter on the incidence of CRI, evaluate risk factors and elucidate the epidemiology of CRI.
    Detailed Description
    Intravascular devices are an integral component of modern-day medical practice. They are used to administer intravenous fluids, medications, blood products and parenteral nutrition. In addition, they serve as a valuable monitor of the hemodynamic status of critically ill patients. Infection is one of the leading complications of intravascular catheters and is associated with an increased mortality, prolonged hospitalization and increased medical costs. Central venous catheters(CVCs) account for an estimated 90% of all catheter-related bloodstream infections(CRBSI). A host of risk factors for CVC-related infections have been documented. This includes, most importantly, the duration of catheterization. The duration of use of CVCs remains controversial and the length of time such devices can safely be left in situ has not been fully and objectively addressed in the critically ill patient. As a consequence, scheduled replacement remains widely practiced in many Intensive Care Units(ICUs),the mean time in a recent study in mainland Britain, being 6.5 days.Over the past few years, antimicrobial impregnated catheters have been introduced in an attempt to limit catheter-related infection(CRI) and increase the time that CVCs can safely be left in place.Recent meta-analyses concluded that antimicrobial-impregnated CVCs appear to be effective in reducing CRI.The topic remains extremely controversial with differing viewpoints appearing in the literature. This was a prospective randomized double-blind study performed in the multidisciplinary ICU at Johannesburg Hospital, Johannesburg, South Africa over a four year period. The study included 118 critically ill patients and entailed comparison of a 14-day placement of a standard triple-lumen central venous catheter (ARROW Standard Triple Lumen Catheter, Arrow International Inc., Reading, PA, US) versus an antimicrobial impregnated catheter (chlorhexidine-silver sulfadiazine)(ARROWgard Triple Lumen Catheter, Arrow International Inc.,Reading, PA, US) on the rate of CRI. The aim was to: Determine whether the duration of catheter insertion time could safely be increased from our standard practice of seven days to fourteen days To assess the influence of the antimicrobial impregnated catheter on the incidence of CRI To evaluate other previously recorded risk factors for CRI, as well as to Elucidate the epidemiology of CRI. The randomization protocol involved equal numbers of the two types of non-distinguishable catheters being mixed in consignments and then selected in a consecutive fashion for placement in study candidates. Consent was obtained prior to enrollment in the study. Standard infection control measures were practiced with catheter insertion. Skin swabs were taken for culture prior to cleansing with a chlorhexidine containing solution and subsequent catheter insertion. Catheters were inspected and dressed daily, and studied for colonization and CRBSI at removal. The origin of each CRBSI was sought by culturing all potential sources (skin, catheter segments, hubs and infusates). A semiquantitative culture of the catheters using the roll-plate technique was performed and DNA-molecular typing employed to assist in microbiological analyses. All relevant clinical data was collected and evaluated. CRI was defined according to the criteria proposed by the Centers for Disease Control and Prevention in the USA. The study was approved by the Committee for Research on Human Subjects of the University of the Witwatersrand.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critically Ill Patients, Infection
    Keywords
    Central venous catheters, Antimicrobial impregnated catheters, Duration of catheter use, Catheter-related infection, Insertion site, Parenteral nutrition, Critically ill patients (multidisciplinary)

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    118 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    5592
    Arm Type
    No Intervention
    Arm Description
    Standard triple lumen catheter
    Arm Title
    5593
    Arm Type
    Active Comparator
    Arm Description
    Antimicrobial impregnated catheter (chlorhexidine silver-sulfadiazine)
    Intervention Type
    Device
    Intervention Name(s)
    Antimicrobial impregnated catheter (5593)
    Other Intervention Name(s)
    ARROW Standard Triple Lumen Catheter, ARROWgard Triple Lumen Catheter
    Intervention Description
    Comparison of 14-day placement of a standard triple lumen (ARROW Standard Triple Lumen Catheter, Arrow International Inc., Reading, PA, US) versus an antimicrobial impregnated catheter (Chlorhexidine-silver sulfadiazine)(ARROWgard Triple Lumen Catheter, Arrow International Inc., Reading, PA, US)
    Primary Outcome Measure Information:
    Title
    To determine the influence of antimicrobial impregnated catheters on the incidence of catheter-related infection and whether CVCs can safely be left in place for a period of up to 14 days in critically ill patients
    Time Frame
    14 days of catheter placement
    Secondary Outcome Measure Information:
    Title
    To elucidate the epidemiology and risks of catheter-related infection in a population of critically ill patients
    Time Frame
    14 day catheter placement

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: critically ill patients likely to require central venous catheter for at least 14 days age 18+ years white cell count on admission > 4 x 10 to 9/L absence of skin burns no history of allergy to sulfa containing preparations consent obtained catheter to be inserted via internal jugular or subclavian veins Exclusion Criteria: age < 18 years white blood cell count on admission of less than 4 x 10 to 9/L skin burns history of allergy to sulfa-containing preparations guidewire changes
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mervyn Mer, MBBChFCP(SA)
    Organizational Affiliation
    Department of Medicine, Division of Pulmonology and Critical Care, Johannesburg Hospital and University of the Witwatersrand, Johannesburg, South Africa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Central Venous Catheter-Related Infection

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