Hemodialysis Catheter Blood Stream InfectionPhase 4TEGONCT01082770
Randomised Controlled Trial of Needle Free Access Devices in Preventing Hemodialysis Blood Stream Infection
A Phase 4 study testing TEGO and Standard in people with Hemodialysis Catheter Blood Stream Infection and Central Line Infection, run by Beaumont Hospital at 1 site in Ireland.
Trial summary
This study will be a randomised controlled trial examining whether a new type of needle free access device(TEGO) is associated with less episodes of infection of dialysis lines, when compared to the current gold standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Catheter Blood Stream Infection, Central Line Infection, Dialysis Line Thrombosis
- What is being tested?
- TEGO and Standard
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteIreland
- Study dates
- Mar 2010to Mar 2011
- 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
- Patients recruited will be over 18 and have been on haemodialysis for greater than one month, have permanent cuffed vascular access lines in place and will be receiving haemodialysis through these lines three times per week.
- Patients will not have had a documented episode of bacteraemia or sepsis for greater than 4 weeks, and will not be using antibiotic coated dialysis lines.
Who cannot join
- Patients with immunosuppressive illnesses such as HIV, cancer or patients who regularly use glucocorticoids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial Comparing Bacteraemia Rates in Closed Luer Lock Access Devices(TEGO) With Standard Devices in the Outpatient Haemodialysis Population
This study will be a randomised controlled trial examining whether a new type of needle free access device(TEGO) is associated with less episodes of infection of dialysis lines, when compared to the current gold standard.
The investigators hypothesise that there will be less handling of the dialysis line by nursing staff and thus this will lead to lower rates of infection. The investigators will also assess whether these access devices lead to alterations in catheter blood flow rates when compared to the current gold standard.
Read the detailed description
Introduction
Infection is an important cause of morbidity and mortality in patients with ESKD. Examining the USRDS database, it is the second leading cause of death in these patients . Several studies in the past number of years have highlighted permanent vascular access devices as independent risk factors for the development of sepsis .
Approximately 50% of haemodialysis patients in Beaumont Hospital use permanent central catheters, often while awaiting alternative vascular access, such as arterio-venous fistulae or when other avenues of vascular access have been exhausted. International data has shown that patients with permanent vascular access devices have 50% higher infection rates compared to those with a native fistula .
Permanent central venous catheters used in haemodialysis are tunnelled cuffed dual lumen catheters usually composed of silicone or polyurethane materials. These are usually placed in the right internal jugular vein. Tunnelled haemodialysis catheters are placed in the radiology department under fluoroscopic guidance.
The presence of catheter related bacteraemia is often treated with intravenous antibiotics such as vancomycin or gentamycin, however a study of 100 haemodialysis patients in Ann Int Med in 1997 has shown that attempts to treat bacteraemia without removal of the catheter usually fail . In such cases, removal of the catheter and insertion of another at either the same or another site is necessary.
Methods of reducing catheter related bacteraemia such as intensive hygiene education, the use of cuffed catheters and the use of prophylactic antibiotic therapy have all been employed, however with limited success
It is hypothesised that repeated opening and handling of the catheter increase the risk of bacteraemia, and so a closed luer lock access device would reduce bacteraemia rates.
Several studies have shown reductions in catheter bacteraemia when closed luer lock devices were used in an ITU setting . Little data exists on infection rates in out patient haemodialysis setting.
A recent study in NDT examining the blood flow resistance of these closed lock access devices show values within safe ranges, suggesting that these devices can safely be used in the out patient haemodialysis setting.
Objective
To identify if a closed luer lock access devices can result in lower rates of bacteraemia and/or sepsis in patients receiving haemodialysis through a permanent vascular catheter when compared to current practise methods.
Primary End Points:
Episodes of bacteraemia or line sepsis requiring antibiotic therapy. Bacteraemia will be defined as positive blood culture specimen.
Bacteraemia will be defined as any episode of temperature > 38º or <36º will be an indication to perform blood cultures, as will cellulitis around catheter sites. A positive blood culture result will be labelled a catheter related bacteraemia if no other obvious source of infection is noted. The physician attending the patient for the above reasons will perform a full physical exam and request an MSU if possible from all patients seen to aid accuracy of results.
Secondary End Points:
Renal blood flow rates in the closed luer lock devices when compared to the standard access devices.
Renal blood flow rates will be recorded by the haemodialysis nursing staff at each dialysis session.
Incidence of line obstruction requiring thrombolytic therapy in the closed luer lock device when compared to standard devices.
Incidence of thrombolytic use will be recorded by the attending haemodialysis nurse.
This study hypothesises that closed luer lock access devices will lead to significantly reduced rates of catheter related bacteraemia, and thus reduced patient morbidity and mortality. It is also hypothesised that renal blood flow rates will be higher in the TEGO study group
Methods
This study will be designed as a one centre prospective randomised case control study, taking place in Beaumont Hospital in St Martin's dialysis wards and St Peter's dialysis ward over a twelve month period.
It shall run from December 2009 to December 2010, with the aim of recruiting 100 patients for the study, 50 patients in the control group and 50 in the treatment group. All patients will receive fully informed written consent prior to entering the trial.
Patients will be randomised into both groups using sequentially numbered, opaque sealed envelopes.
Patients may withdraw from the study at any time with no implications for his/her haemodialysis treatment regime. Patients who undergo transplantation during the trial will be removed from the study at that time, and data collected up to the time of transplantation will be incorporated into the study.
Inclusion criteria Patients recruited will be over 18 and have been on haemodialysis for greater than one month, have permanent cuffed vascular access lines in place and will be receiving haemodialysis through these lines three times per week.
Patients will not have had a documented episode of bacteraemia or sepsis for greater than 4 weeks, and will not be using antibiotic coated dialysis lines.
Exclusion criteria Patients with immunosuppressive illnesses such as HIV, cancer or patients who regularly use glucocorticoids.
Study group Patients in the study group will use TEGO® devices on both access ports, which will be changed after one week or 25 uses. This device which costs €2.30, and will be supplied gratis by Fannin Ltd Dublin and ICU Medical Inc, San Clemente USA.
TEGO® devices will be accessed by the haemodialysis nursing staff using aseptic technique.
Control group Patients in the control group will continue to receive haemodialysis using the current standard of care protocol.
Data Collection Bacteraemia rates from each group will be recorded by the haemodialysis nursing staff and subsequently will be inputted into a Microsoft Excel spreadsheet. Further analysis including comparison of both patient groups will take place using SPSS software. Data will only be stored on a hospital server, and will only be accessible by members of the research team.
The power of the study will be calculated using Fisher's combined probability test, where Test Ho: p1=p2, where p1 is in proportion in population 1 and p2 is in proportion in population 2. Assumptions:
Alpha = 0.0500 (two sided) Power = 0.8000 P1 = 0.17 P2 = 0.000 N2/N1 = 1.00
Estimated sample sizes
N1 = 53 N2 = 53
Subsequent data analysis will include comparison of outcomes using a student's t test and subsequent formation of Kaplan Meier curves.
- Conditions
- Hemodialysis Catheter Blood Stream Infection, Central Line Infection, Dialysis Line Thrombosis
- Being tested
- TEGO, Standard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEGODevice
A bung that can be attached to the end of dialysis lines that can be directly attached to the dialysis machine with minimal handling
StandardDevice
Patients in this group will have a normal 'bung' placed at the end of their dialysis line, which will need to be removed by nursing staff prior to initiation of dialysis
| Study group | Role | What they receive |
|---|---|---|
| TEGO | Active comparator | TEGO needle free access devices will be used in patients randomised to this arm Receives: Device: TEGO |
| Control | Placebo comparator | Patients will continue to receive current standard of practice, ie a 'bung' cap at the end of the hemodialysis line Receives: Device: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteraemia rates in the needle free access devices(TEGO) when compared to current practice
New needle free access devices will be compared to current 'bung' devices. Patients will be randomly assigned to both groups, and rates of bacteraemia will be compared between both groups
Measured: 1 year
Secondary outcomes (2)
Catheter blood flow rates in study device compared to control
Safety of new TEGO, needle free access device will be assessed by measuring the catheter blood flow rates in the study group compared to the control group
Measured: 1 year
Rates of line thrombosis in study group compared to control group
Rates of line thrombosis requiring t-PA administration will be compared in the study group and the control group
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis Catheter Blood Stream InfectionStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Peter Conlon, MD, Study chair, Beaumont Hospital Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082770
- Sponsor's protocol ID
- TEGOIRL
- Acronym
- TEGO
- Status last verified
- Jan 2010
- First submitted
- 8 Mar 2010
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing Bacteraemia Rates in Closed Luer Lock Access Devices(TEGO) With Standard Devices in the Outpatient Haemodialysis Population
- ClinicalTrials.gov ID
- NCT01082770
- Acronym / sponsor ID
- TEGO / TEGOIRL
- Conditions
- Hemodialysis Catheter Blood Stream Infection, Central Line Infection, Dialysis Line Thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 9 Mar 2010 (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.
This study will be a randomised controlled trial examining whether a new type of needle free access device(TEGO) is associated with less episodes of infection of dialysis lines, when compared to the current gold standard.
The investigators hypothesise that there will be less handling of the dialysis line by nursing staff and thus this will lead to lower rates of infection. The investigators will also assess whether these access devices lead to alterations in catheter blood flow rates when compared to the current gold standard.
Detailed description
Introduction
Infection is an important cause of morbidity and mortality in patients with ESKD. Examining the USRDS database, it is the second leading cause of death in these patients . Several studies in the past number of years have highlighted permanent vascular access devices as independent risk factors for the development of sepsis .
Approximately 50% of haemodialysis patients in Beaumont Hospital use permanent central catheters, often while awaiting alternative vascular access, such as arterio-venous fistulae or when other avenues of vascular access have been exhausted. International data has shown that patients with permanent vascular access devices have 50% higher infection rates compared to those with a native fistula .
Permanent central venous catheters used in haemodialysis are tunnelled cuffed dual lumen catheters usually composed of silicone or polyurethane materials. These are usually placed in the right internal jugular vein. Tunnelled haemodialysis catheters are placed in the radiology department under fluoroscopic guidance.
The presence of catheter related bacteraemia is often treated with intravenous antibiotics such as vancomycin or gentamycin, however a study of 100 haemodialysis patients in Ann Int Med in 1997 has shown that attempts to treat bacteraemia without removal of the catheter usually fail . In such cases, removal of the catheter and insertion of another at either the same or another site is necessary.
Methods of reducing catheter related bacteraemia such as intensive hygiene education, the use of cuffed catheters and the use of prophylactic antibiotic therapy have all been employed, however with limited success
It is hypothesised that repeated opening and handling of the catheter increase the risk of bacteraemia, and so a closed luer lock access device would reduce bacteraemia rates.
Several studies have shown reductions in catheter bacteraemia when closed luer lock devices were used in an ITU setting . Little data exists on infection rates in out patient haemodialysis setting.
A recent study in NDT examining the blood flow resistance of these closed lock access devices show values within safe ranges, suggesting that these devices can safely be used in the out patient haemodialysis setting.
Objective
To identify if a closed luer lock access devices can result in lower rates of bacteraemia and/or sepsis in patients receiving haemodialysis through a permanent vascular catheter when compared to current practise methods.
Primary End Points:
Episodes of bacteraemia or line sepsis requiring antibiotic therapy. Bacteraemia will be defined as positive blood culture specimen.
Bacteraemia will be defined as any episode of temperature > 38º or <36º will be an indication to perform blood cultures, as will cellulitis around catheter sites. A positive blood culture result will be labelled a catheter related bacteraemia if no other obvious source of infection is noted. The physician attending the patient for the above reasons will perform a full physical exam and request an MSU if possible from all patients seen to aid accuracy of results.
Secondary End Points:
Renal blood flow rates in the closed luer lock devices when compared to the standard access devices.
Renal blood flow rates will be recorded by the haemodialysis nursing staff at each dialysis session.
Incidence of line obstruction requiring thrombolytic therapy in the closed luer lock device when compared to standard devices.
Incidence of thrombolytic use will be recorded by the attending haemodialysis nurse.
This study hypothesises that closed luer lock access devices will lead to significantly reduced rates of catheter related bacteraemia, and thus reduced patient morbidity and mortality. It is also hypothesised that renal blood flow rates will be higher in the TEGO study group
Methods
This study will be designed as a one centre prospective randomised case control study, taking place in Beaumont Hospital in St Martin's dialysis wards and St Peter's dialysis ward over a twelve month period.
It shall run from December 2009 to December 2010, with the aim of recruiting 100 patients for the study, 50 patients in the control group and 50 in the treatment group. All patients will receive fully informed written consent prior to entering the trial.
Patients will be randomised into both groups using sequentially numbered, opaque sealed envelopes.
Patients may withdraw from the study at any time with no implications for his/her haemodialysis treatment regime. Patients who undergo transplantation during the trial will be removed from the study at that time, and data collected up to the time of transplantation will be incorporated into the study.
Inclusion criteria Patients recruited will be over 18 and have been on haemodialysis for greater than one month, have permanent cuffed vascular access lines in place and will be receiving haemodialysis through these lines three times per week.
Patients will not have had a documented episode of bacteraemia or sepsis for greater than 4 weeks, and will not be using antibiotic coated dialysis lines.
Exclusion criteria Patients with immunosuppressive illnesses such as HIV, cancer or patients who regularly use glucocorticoids.
Study group Patients in the study group will use TEGO® devices on both access ports, which will be changed after one week or 25 uses. This device which costs €2.30, and will be supplied gratis by Fannin Ltd Dublin and ICU Medical Inc, San Clemente USA.
TEGO® devices will be accessed by the haemodialysis nursing staff using aseptic technique.
Control group Patients in the control group will continue to receive haemodialysis using the current standard of care protocol.
Data Collection Bacteraemia rates from each group will be recorded by the haemodialysis nursing staff and subsequently will be inputted into a Microsoft Excel spreadsheet. Further analysis including comparison of both patient groups will take place using SPSS software. Data will only be stored on a hospital server, and will only be accessible by members of the research team.
The power of the study will be calculated using Fisher's combined probability test, where Test Ho: p1=p2, where p1 is in proportion in population 1 and p2 is in proportion in population 2. Assumptions:
Alpha = 0.0500 (two sided) Power = 0.8000 P1 = 0.17 P2 = 0.000 N2/N1 = 1.00
Estimated sample sizes
N1 = 53 N2 = 53
Subsequent data analysis will include comparison of outcomes using a student's t test and subsequent formation of Kaplan Meier curves.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEGO | Active comparator | Device: TEGOTEGO needle free access devices will be used in patients randomised to this arm |
| Control | Placebo comparator | Device: StandardPatients will continue to receive current standard of practice, ie a 'bung' cap at the end of the hemodialysis line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients recruited will be over 18 and have been on haemodialysis for greater than one month, have permanent cuffed vascular access lines in place and will be receiving haemodialysis through these lines three times per week.
- Patients will not have had a documented episode of bacteraemia or sepsis for greater than 4 weeks, and will not be using antibiotic coated dialysis lines.
Key exclusion criteria (1 listed)
- Patients with immunosuppressive illnesses such as HIV, cancer or patients who regularly use glucocorticoids.
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 |
|---|---|---|
| TEGOA bung that can be attached to the end of dialysis lines that can be directly attached to the dialysis machine with minimal handling | Device | TEGO |
| StandardPatients in this group will have a normal 'bung' placed at the end of their dialysis line, which will need to be removed by nursing staff prior to initiation of dialysis | Device | Control |
Primary outcome
Bacteraemia rates in the needle free access devices(TEGO) when compared to current practice
Time frame: 1 year
New needle free access devices will be compared to current 'bung' devices. Patients will be randomly assigned to both groups, and rates of bacteraemia will be compared between both groups
2 secondary outcomes
Catheter blood flow rates in study device compared to control
Time frame: 1 year
Rates of line thrombosis in study group compared to control group
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
Related trials for Hemodialysis Catheter Blood Stream Infection
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Prophylactic Antibiotic Treatment in Hemodialysis
Hemodialysis
Not yet recruiting
Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial
Vascular Access Complication, Device Related Infection
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.
Peter Conlon, MD study chair
Beaumont Hospital Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TEGO and Standard in people with Hemodialysis Catheter Blood Stream Infection and Central Line Infection, run by Beaumont Hospital at 1 site in Ireland.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Bacteraemia rates in the needle free access devices(TEGO) when compared to current practice (time frame: 1 year). 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 9 Mar 2010.