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Clinical Trials/EUCTR2010-019984-12-IE
EUCTR2010-019984-12-IE
Active, not recruiting
Not Applicable

A multicentre randomised trial comparing the effects of 2% chlorhexidine gluconate in 70% isopropyl alcohol as a skin, exit site and catheter hub cleansing agent versus other forms of chlorhexidine gluconate which are in routine use, on central venous catheter-related infections in haemodialysis patients

Adelaide & Meath Hospital, incorporating The National Children's Hospital0 sites180 target enrollmentMay 18, 2010
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ConditionsPrevention of central venous catheter-related infections in haemodialysis patients.This trial will evaluate the effectiveness of 2% chlorhexidine gluconate in 70%isopropyl alcohol as a skin, exit site and catheter hub cleansing agent in the reduction of CVC-related infections in haemodialysis patients, in comparison to the other forms of chlorhexidine gluconate that are in routine use in dialysis centres in Ireland.
DrugsChloraPrep® with Tint 2% w/v / 70% v/v cutaneous solutionSterets UniseptHydrex® Pink Chlorhexidine Gluconate 0.5% W/V in 70% V/V DEB

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prevention of central venous catheter-related infections in haemodialysis patients.This trial will evaluate the effectiveness of 2% chlorhexidine gluconate in 70%isopropyl alcohol as a skin, exit site and catheter hub cleansing agent in the reduction of CVC-related infections in haemodialysis patients, in comparison to the other forms of chlorhexidine gluconate that are in routine use in dialysis centres in Ireland.
Sponsor
Adelaide & Meath Hospital, incorporating The National Children's Hospital
Enrollment
180
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 18, 2010
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Adelaide & Meath Hospital, incorporating The National Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • •Patients over the age of 18 who require haemodialysis for end stage renal disease (ESRD)
  • •Patients on long term haemodialysis using a permanent tunnelled cuffed CVC
  • •Patients whose permanent tunnelled cuffed CVC has been inserted at least four weeks prior to entry into the study (to avoid recruiting patients who may develop infection secondary to insertion technique)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Patients whose CVC is used for purposes other than access for haemodialysis
  • •Patients with a known allergy to any component of the interventions
  • •Patients whose CVC material is not compatible with interventions
  • •Patients who are using central venous catheters or dressings which are not standard practice for the unit
  • •Patients who are unable to give informed consent

Outcomes

Primary Outcomes

Not specified

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