Central Venous Catheter-Related Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00533988
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : October 1, 2007
Information provided by:
University of Witwatersrand, South Africa

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.

Condition or disease Intervention/treatment Phase
Critically Ill Patients Infection Device: Antimicrobial impregnated catheter (5593) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Central Venous Catheter-Related Infection: A Prospective Randomized Double-Blind Study
Study Start Date : January 1996
Actual Study Completion Date : December 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 5592
Standard triple lumen catheter
Active Comparator: 5593
Antimicrobial impregnated catheter (chlorhexidine silver-sulfadiazine)
Device: Antimicrobial impregnated catheter (5593)
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)
Other Names:
  • ARROW Standard Triple Lumen Catheter
  • ARROWgard Triple Lumen Catheter

Primary Outcome Measures :
  1. 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 Measures :
  1. To elucidate the epidemiology and risks of catheter-related infection in a population of critically ill patients [ Time Frame: 14 day catheter placement ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00533988

Sponsors and Collaborators
University of Witwatersrand, South Africa
Principal Investigator: Mervyn Mer, MBBChFCP(SA) Department of Medicine, Division of Pulmonology and Critical Care, Johannesburg Hospital and University of the Witwatersrand, Johannesburg, South Africa Identifier: NCT00533988     History of Changes
Other Study ID Numbers: 94/4/4.1;7902114
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: October 1, 2007
Last Verified: September 2007

Keywords provided by University of Witwatersrand, South Africa:
Central venous catheters
Antimicrobial impregnated catheters
Duration of catheter use
Catheter-related infection
Insertion site
Parenteral nutrition
Critically ill patients (multidisciplinary)

Additional relevant MeSH terms:
Communicable Diseases
Critical Illness
Catheter-Related Infections
Disease Attributes
Pathologic Processes
Anti-Infective Agents
Silver Sulfadiazine
Anti-Bacterial Agents
Anti-Infective Agents, Local