Critically Ill PatientsPhase 4NCT00533988
Central Venous Catheter-Related Infection
A Phase 4 study testing Antimicrobial impregnated catheter (5593) in people with Critically Ill Patients and Infection, run by University of Witwatersrand, South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients, Infection
- What is being tested?
- Antimicrobial impregnated catheter (5593)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- Jan 1996to Dec 1999
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Central Venous Catheter-Related Infection: A Prospective Randomized Double-Blind Study
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.
Read the 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.
- Conditions
- Critically Ill Patients, Infection
- Being tested
- Antimicrobial impregnated catheter (5593)
- Keywords
- Central venous catheters, Antimicrobial impregnated catheters, Duration of catheter use, Catheter-related infection, Insertion site, Parenteral nutrition, Critically ill patients (multidisciplinary)
- Medical subject headings
- Infections, Catheter-Related Infections, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial impregnated catheter (5593)Device
Also called ARROW Standard Triple Lumen Catheter, ARROWgard Triple Lumen Catheter
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)
| Study group | Role | What they receive |
|---|---|---|
| 5592 | No intervention | Standard triple lumen catheter |
| 5593 | Active comparator | Antimicrobial impregnated catheter (chlorhexidine silver-sulfadiazine) Receives: Device: Antimicrobial impregnated catheter (5593) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days of catheter placement
Secondary outcomes (1)
To elucidate the epidemiology and risks of catheter-related infection in a population of critically ill patients
Measured: 14 day catheter placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startJan 1996
- Study completionDec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Investigators
- Mervyn Mer, MBBChFCP(SA), Principal investigator, Department of Medicine, Division of Pulmonology and Critical Care, Johannesburg Hospital and University of the Witwatersrand, Johannesburg, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533988
- Sponsor's protocol ID
- 94/4/4.1;7902114
- Status last verified
- Sep 2007
- First submitted
- 21 Sep 2007
- Last updated
- 1 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Venous Catheter-Related Infection: A Prospective Randomized Double-Blind Study
- ClinicalTrials.gov ID
- NCT00533988
- Acronym / sponsor ID
- 94/4/4.1;7902114
- Conditions
- 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)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Study start
- Jan 1996
- Study completion
- Dec 1999 (actual)
- First posted
- 24 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5592 | No intervention | –Standard triple lumen catheter |
| 5593 | Active comparator | Device: Antimicrobial impregnated catheter (5593)Antimicrobial impregnated catheter (chlorhexidine silver-sulfadiazine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antimicrobial impregnated catheter (5593)Also: ARROW Standard Triple Lumen Catheter, ARROWgard Triple Lumen CatheterComparison 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) | Device | 5593 |
Primary outcome
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
1 secondary outcome
To elucidate the epidemiology and risks of catheter-related infection in a population of critically ill patients
Time frame: 14 day catheter placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mervyn Mer, MBBChFCP(SA) principal investigator
Department of Medicine, Division of Pulmonology and Critical Care, Johannesburg Hospital and University of the Witwatersrand, Johannesburg, South Africa
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antimicrobial impregnated catheter (5593) in people with Critically Ill Patients and Infection, run by University of Witwatersrand, South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2007.