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Randomised Controlled Trial of Needle Free Access Devices in Preventing Hemodialysis Blood Stream Infection (TEGO)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Beaumont Hospital
ClinicalTrials.gov Identifier:
NCT01082770
First received: March 8, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention Phase
Hemodialysis Catheter Blood Stream Infection
Central Line Infection
Dialysis Line Thrombosis
 Device: TEGO
Device: Standard
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Beaumont Hospital:

Primary Outcome Measures:
  • Bacteraemia rates in the needle free access devices(TEGO) when compared to current practice [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Catheter blood flow rates in study device compared to control [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Rates of line thrombosis requiring t-PA administration will be compared in the study group and the control group


Estimated Enrollment: 106
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082770

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

No publications provided

Responsible Party: Professor Peter Conlon, Beaumont Hospital, Dublin 9, Ireland
ClinicalTrials.gov Identifier: NCT01082770     History of Changes
Other Study ID Numbers: TEGOIRL
Study First Received: March 8, 2010
Last Updated: March 8, 2010
Health Authority: Ireland: Medical Ethics Research Committee

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

ClinicalTrials.gov processed this record on May 16, 2013