Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT01082770 |
| Other study ID # |
TEGOIRL |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
Phase 4
|
| First received |
March 8, 2010 |
| Last updated |
March 8, 2010 |
| Start date |
March 2010 |
| Est. completion date |
March 2011 |
Study information
| Verified date |
January 2010 |
| Source |
Beaumont Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Ireland: Medical Ethics Research Committee |
| Study type |
Interventional
|
Clinical 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.
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.
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.
