Randomised Controlled Trial of Needle Free Access Devices in Preventing Hemodialysis Blood Stream Infection (TEGO)
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|ClinicalTrials.gov Identifier: NCT01082770|
Recruitment Status : Unknown
Verified January 2010 by Beaumont Hospital.
Recruitment status was: Enrolling by invitation
First Posted : March 9, 2010
Last Update Posted : March 9, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemodialysis Catheter Blood Stream Infection Central Line Infection Dialysis Line Thrombosis||Device: TEGO Device: Standard||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Controlled Trial Comparing Bacteraemia Rates in Closed Luer Lock Access Devices(TEGO) With Standard Devices in the Outpatient Haemodialysis Population|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||March 2011|
|Estimated Study Completion Date :||March 2011|
Active Comparator: TEGO
TEGO needle free access devices will be used in patients randomised to this arm
A bung that can be attached to the end of dialysis lines that can be directly attached to the dialysis machine with minimal handling
Placebo Comparator: Control
Patients will continue to receive current standard of practice, ie a 'bung' cap at the end of the hemodialysis line
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
- 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
- Catheter blood flow rates in study device compared to control [ Time Frame: 1 year ]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
- Rates of line thrombosis in study group compared to control group [ Time Frame: 1 year ]Rates of line thrombosis requiring t-PA administration will be compared in the study group and the control group
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 ClinicalTrials.gov identifier (NCT number): NCT01082770
|Dublin, Ireland, 9|
|Study Chair:||Peter Conlon, MD||Beaumont Hospital Dublin|