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.
Conditions
Interventions
Trade Name: ChloraPrep® with Tint 2% w/v / 70% v/v cutaneous solution
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: CHLORHEXIDINE GLUCONATE
CAS Number: 18472510
Concentration unit: % (
Sponsors
Adelaide & Meath Hospital, incorporating The National Children's Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of 2% chlorhexidine gluconate in 70% isopropyl alcohol versus 0.05% aqueous chlorhexidine gluconate or 0.5% chlorhexidine gluconate in 70% isopropyl alcohol, on the reduction of CVC-related infections (catheter-associated bloodstream infections, catheter-related bloodstream infection and local access infection) in haemodialysis patients.;Primary end point(s): The primary end point with be bloodstream infection secondary to central venous catheter. The CDC/NHSN Laboratory Confirmed Primary Bloodstream Infection definitions (2008) and the Infectious Disease Society of America’s Clinical Definitions of Catheter-related Infections (2009) will be used to diagnose catheter-associated bloodstream infection and catheter-related bloodstream infection (CRBSI). To enable comparisons with International literature the CDC/NHSN (2009) Dialysis Events specific outcomes measures will also be included. These outcomes are local access infection, access-associated bacteraemia and vascular access infection. The CDC/NHSN Dialysis Events specific outcomes measures are: •Local access infection: Pus, redness or swelling of the vascular access site and access-associated bacteraemia was not present and patient was hospitalised or had initiation of an IV antimicrobial agent. •Access-associated bacteraemia: Positive blood culture with source identified as the vascular access site or unknown. •Vascular access infection: Either local infection or access-associated bacteraemia Bloodstream infections can be classified as either catheter-associated or catheter-related. According to the CDC/NHSN (2008) laboratory confirmed primary bloodstream infections are recorded as catheter-associated bloodstream infections if a CVC was in place at the time of or within 48 hours before the development of the BSI. Laboratory Confirmed Bloodstream Infection must meet at least one of the following criteria Criteria 1: Patient has a recognized pathogen cultured | — |
Countries
Ireland
Outcome results
None listed