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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
Sponsor:
Information provided by:
Beaumont Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Hemodialysis Catheter Blood Stream Infection Central Line Infection Dialysis Line Thrombosis Device: TEGO Device: Standard Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: TEGO
TEGO needle free access devices will be used in patients randomised to this arm
Device: TEGO
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
Device: Standard
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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

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.

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 ClinicalTrials.gov identifier (NCT number): NCT01082770


Locations
Ireland
Beaumont Hospital
Dublin, Ireland, 9
Sponsors and Collaborators
Beaumont Hospital
Investigators
Study Chair: Peter Conlon, MD Beaumont Hospital Dublin

Responsible Party: Professor Peter Conlon, Beaumont Hospital, Dublin 9, Ireland
ClinicalTrials.gov Identifier: NCT01082770     History of Changes
Other Study ID Numbers: TEGOIRL
First Posted: March 9, 2010    Key Record Dates
Last Update Posted: March 9, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Infection
Communicable Diseases
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases