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

NCT01082770 | Unknown Phase 4 DMC

• 1 other identifier: TEGOIRL
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Catheter Blood Stream Infection; Central Line Infection; Dialysis Line Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (2)

• Catheter blood flow rates in study device compared to control

  1 year

• Rates of line thrombosis in study group compared to control group

  1 year

Study Arms (2)

TEGO

ACTIVE COMPARATOR

TEGO needle free access devices will be used in patients randomised to this arm

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

Device: Standard

Interventions

TEGO DEVICE

A bung that can be attached to the end of dialysis lines that can be directly attached to the dialysis machine with minimal handling

TEGO

Standard DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with immunosuppressive illnesses such as HIV, cancer or patients who regularly use glucocorticoids.

Sponsors & Collaborators

• Beaumont Hospital: lead

Study Sites (1)

Beaumont Hospital

Dublin, Dublin, 9, Ireland

Location

MeSH Terms

Interventions

Reference Standards

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Study Officials

• Peter Conlon, MD

  Beaumont Hospital Dublin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 9, 2010

Record last verified: 2010-01

Locations

IE (1)