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
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
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
NCT ID
NCT00533988
First Posted
September 21, 2007
Last Updated
September 28, 2007
Sponsor
University of Witwatersrand, South Africa
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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