Plain English Summary
Background and study aims
People whose kidneys fail rely on dialysis machines (usually three times weekly) to clean their blood from waste products. Dialysis treatment requires access to the patient’s circulation, which is sometimes achieved by inserting a plastic tube (catheter) into a major vein in the body. Two major complications are associated with the use of catheters: catheter occlusion due to clot formation inside or outside the catheter lumen, and infection that can lead to serious blood poisoning (bloodstream infection), which is a major cause of death in this group of patients. Usually an anticoagulant solution called Heparin is instilled and locked inside the catheter between dialysis sessions to prevent catheter occlusion. Research has shown that Heparin encourages bacterial growth on the catheter’s surface and may contribute to infection. A lock solution that prevents catheter occlusion and infection would be ideal to address the two major complications associated with catheters use. Cathasept lock solution has anticoagulant and anti-microbial effects. The aim of this study is to assess the effectiveness of Cathasept line lock to reduce microbial colonization of hemodialysis catheters.
Who can participate?
People receiving dialysis treatment at four dialysis centers in the Yorkshire region in the UK.
What does the study involve?
Patients who were deemed eligible and provided informed consent, were randomly assigned to either continue Heparin locks or to receive Cathasept locks. Participants were regularly checked for signs of infection and were tested weekly for catheter infection by obtaining 1 ml of blood through the catheter lumens and sent for microbial culture.
What are the possible benefits and risks of participating?
Benefits include reduction in catheter-related infections with lower hospital admissions, improved general wellbeing, and reduced cost. However, Cathasept may not be as effective an anticoagulant as Heparin, which may result in higher incidence of catheter occlusion.
Where is the study run from?
Four dialysis centers in the Yorkshire region in the UK
When is the study starting and how long is it expected to run for?
August 2006 to October 2008
Who is funding the study?
Yorkshire Kidney Research Fund (UK)
Who is the main contact?
Dr Muhammad Kanaa
muhammad.kanaa@dbh.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Muhammad Kanaa
ORCID ID
Contact details
Department of Renal Medicine
Doncaster Royal Infirmary
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
+44 (0)1302 366666 ext 4750
muhammad.kanaa@dbh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
337.23
Study information
Scientific title
Multi-center, prospective, randomised, controlled study to assess the efficacy of Cathasept line lock to reduce microbial colonization of tunneled hemodialysis catheters
Acronym
Study hypothesis
Null hypothesis: There is no statistically significant difference in the percentage of cases with colonised catheters between the Cathasept group and the heparin group.
Ethics approval
Leeds (West) Medical Research Ethics Committee, 07/03/2006, ref: 05/Q1205/241
Study design
Multi-center prospective randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Microbial colonisation of tunnelled haemodialysis catheters
Intervention
Eligible participants were randomly assigned to have their catheter locked with standard Heparin 5000 units/ml (control group) or with Cathasept (intervention group). Participants underwent weekly culture of 1 ml of blood aspirated from their catheters to check for microbial colonisation and were monitored for signs of infection and catheter dysfunction. Participants were followed up until their catheter was removed or for 8 months if the catheter was not removed.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Incidence rate of clinically significant microbial colonization of t-HDC per 1000 catheter-days, defined as TCQBC yielding ≥1000 CFU/ml of bacteria or yeast.
Secondary outcome measures
1. Incidence rate of CRBSI
2. Number of dialysis sessions where the prescribed blood flow was achieved
3. Incidence rate of interventions to improve catheter patency including intra-catheter lock or infusion of thrombolytic agents
4. Difference between both groups for hemoglobin, hs-CRP, serum ferritin, Kt/V, and iron and erythropoietin-stimulating requirements. Kt/V is a measurement used to quantify dialysis treatment adequacy (K is the dialyzer clearance of urea, t is the time spent on dialysis that day and not the prescribed time on dialysis, and V is the volume of distribution of urea which is approximately equal to total body water).
Overall trial start date
01/08/2006
Overall trial end date
31/10/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Able to provide informed consent
2. History of established renal failure (ERF)
3. Starting or undergoing hemodialysis using a t-HDC in an internal jugular or subclavian vein
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant exclusion criteria
1. Any medical, social or psychological condition that would compromise participation and follow-up in the study
2. Females who were pregnant or lactating
3. Patients who had a tunneled catheter with an expected duration of placement or use of less than 60 days
4. Patients enrolled in another clinical study, or had participated in the study
5. Life expectancy of less than 3 months
6. Patients with existing tunneled central venous catheters who had positive blood cultures or received antimicrobial therapy, including antibiotic lock solution and/or antimicrobial catheters, for documented or suspected CRBSI within 14 days prior to enrolment
7. Evidence of systemic infection or catheter exit site infection at the time of enrolment
8. Patients with colonized catheters (screening quantitative through catheter blood cultures (QTCBC) yielding >20 cfu/ml bacteria or yeasts)
9. Patients whose catheters demonstrated signs of dysfunction in two or more dialysis sessions during the last two weeks prior to enrolment. These signs were defined as:
9.1. Blood flow rate < 200 ml/min, or prescribed blood flow rate was not achieved, OR
9.2. Elevated venous pressure (>250 mmHg), or negative arterial pressure of greater than (-250 mmHg), OR
9.3. Line reversal (using the arterial port to aspirate and the venous port to return blood)
10. A known sensitivity to heparin, disodium EDTA, or natural rubber latex
Recruitment start date
01/08/2006
Recruitment end date
31/08/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Teaching Hospitals NHS Trust
LS9 7TF
United Kingdom
Trial participating centre
Bradford Teaching Hospitals NHS Foundation Trust
BD5 0NA
United Kingdom
Trial participating centre
York Teaching Hospital NHS Foundation Trust
YO31 8HE
United Kingdom
Trial participating centre
Hull and East Yorkshire Hospitals NHS Trust and Hull York Medical School
HU3 2JZ
United Kingdom
Funders
Funder type
Charity
Funder name
Yorkshire Kidney Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study is currently being considered for publication - a revised manuscript has been submitted.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26141306