Pilot randomised trial comparing the effect of different strengths of an antiseptic solution, chlorhexidine gluconate, on central venous catheter related infections in haemodialysis patients in three outpatient haemodialysis centres

ISRCTN	ISRCTN26577745
DOI	https://doi.org/10.1186/ISRCTN26577745
Protocol serial number	EudraCT number 2010-019984-12; Sponsors Protocol Code Number Prot-AMNCH-TCD-CHG-1-2010/
Sponsor	Trinity College Dublin (Ireland)
Funders	Trinity College Dublin (Ireland) - School of Nursing and Midwifery, Carefusion Ltd & PDI (Ireland) - providing ChloraPrep® with Tint applicator and Sani-Cloth CHG 2% (These companies will have no influence over the conduct, analysis or reporting of the study)

Submission date: 05/08/2010
Registration date: 31/08/2010
Last edited: 17/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Margaret McCann
Scientific

School of Nursing and Midwifery
Trinity College Dublin
24 D'Olier Street
Dublin
Dublin 2
Ireland

Phone	+353 (0)1 8968542
Email	mccannm1@tcd.ie

Study information

Primary study design	Interventional
Study design	Multicentre open label pilot multicentre randomised trial using a 1:1 randomisation ratio
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study acronym	CHG Trial
Study objectives	There is no difference between 2% chlorhexidine gluconate in 70% alcohol and 0.05% aqueous chlorhexidine gluconate or 0.5% chlorhexidine gluconate in 70% alcohol in the reduction of central venous catheter (CVC) related infections in haemodialysis patients. Please note that as of 21/01/2013, the following changes were made to the trial record: 1. The anticipated start date was updated from 01/09/2010 to 18/10/2010 2. The anticipated end date was updated from 05/09/2012 to 14/09/2012
Ethics approval(s)	Ethical Approval was granted by the Joint St. James Hospital and Adelaide and Meath Hospital, incorporating The National Children's Hospital Research Ethics Committee, on the 12th of July 2010 (ref: 2010/27/03)
Health condition(s) or problem(s) studied	End stage renal disease; haemodialysis; central venous catheter infections
Intervention	All patients assigned to the 'experimental' group will receive 2% chlorhexidine gluconate in 70% alcohol cutaneous solution. Those patients assigned to the 'control' group will receive the chlorhexidine gluconate cutaneous solution that is the standard antiseptic agent used in the routine care of their CVC. There are two different types of routine care in use in the centres that will participate in the randomised trial: 0.5% chlorhexidine gluconate in 70% alcohol and 0.05% aqueous chlorhexidine gluconate. Patients whose routine care is 0.5% chlorhexidine gluconate in 70% alcohol will be randomised to receive either the experimental intervention of 2% chlorhexidine gluconate in 70% alcohol or the routine care of 0.5% chlorhexidine gluconate in 70% alcohol. Similarly, patients whose routine care is 0.05% aqueous chlorhexidine gluconate will be randomised to receive either the experimental intervention of 2% chlorhexidine gluconate in 70% alcohol or routine care of 0.05% aqueous chlorhexidine gluconate. 1. The experimental group will receive 2% chlorhexidine gluconate in 70% alcohol antiseptic cleansing agents in the form of: 1.1. ChloraPrep® with Tint 2% w/v/70%v/v cutaneous solution (3ml applicator) will be used to cleanse the skin and exit site of the central venous catheter when the catheter dressing is changed. Duration of treatment: Subjects will receive this intervention every time the dressing is changed for a period of 12 months. Frequency of dressing change will be determined by local policy. 1.2. Sani Cloth CHG 2% medical device wipe will be used to cleanse the hubs of central venous catheters when connecting or disconnecting patients from dialysis. Duration of treatment: every dialysis session (three times a week) for a period of 12 months 2. Patients allocated to the 'control' group will receive either: 2.1. 0.5% chlorhexidine gluconate in 70% alcohol cutaneous solution (Hydrex Pink) or 2.2. 0.05% aqueous chlorhexidine gluconate cutaneous solution (Unisept) Duration of treatment will be 12 months. Control intervention will be used to cleanse the catheter hubs when connecting and disconnecting patients from dialysis (three times a week) for a period of 12 months. Control intervention will also be used when skin and exit site are cleansed every time the catheter dressing is changed for a period of 12 months. Frequency of dressing change will be determined by local policy. Recruitment will take place over an eight month period. Each patient will be followed up for 12 months. Data capture will be completed in 20 months from the recruitment of the first patient. Patients who develop CVC-associated or related bloodstream infection will be withdrawn from the study. Chief Investigator & Research Sponsor: Dr George Mellotte Department of Nephrology Adelaide & Meath Hospital, incorporating The National Children's Hospital Tallaght Dublin 24
Intervention type	Other
Primary outcome measure(s)	CVC-related infections: 1. Catheter-associated bloodstream infections 2. Catheter-related bloodstreams infection 3. Local access infection Case definitions used in the trial protocol will be those set down by the Infectious Disease Society of America and the Centre for Disease Control and Disease.
Key secondary outcome measure(s)	1. Time to development of first CVC-related infection 2. Patient mortality secondary to infection 3. CVC-related infection rates according to causative organism 4. Time to infection associated catheter removal 5. Episodes of hospitalisation 6. Incidence of adverse reactions 7. Economic Cost 8. Incidence and prevalence of arteriovenous fistula (AVF), arteriovenous graft (AVG) and CVC use in haemodialysis population
Completion date	14/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	180
Key inclusion criteria	1. Patients over the age of 18 who require haemodialysis for end stage renal disease (ESRD) 2. Patients on long term haemodialysis using permanent tunnelled cuffed CVC 3. 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)
Key exclusion criteria	1. Patients whose CVC is used for purposes other than access for haemodialysis 2. Patients with a known allergy to any component of the interventions 3. Patients whose CVC material is not compatible with interventions 4. Patients who are using central venous catheters or dressings which are not standard practice for the unit 5. Patients who are unable to give informed consent
Date of first enrolment	18/10/2010
Date of final enrolment	14/09/2012

Locations

Countries of recruitment

Ireland

Study participating centre

School of Nursing and Midwifery

Dublin
Dublin 2
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2016	17/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/01/2019: The following changes have been made to the trial record:
1. Publication reference added
2. "0.5% chlorhexidine gluconate in 70% isopropyl alcohol changed" to "0.5% chlorhexidine gluconate in 70% alcohol" throughout