Condition category
Infections and Infestations
Date applied
23/03/2015
Date assigned
02/04/2015
Last edited
15/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Tyco Healthcare Group LP d/b/a Covidien (USA)

Sponsor details

Mansfield
Mansfield
02048
United States of America

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26141306

Publication citations

Additional files

Editorial Notes

15/03/2016: Publication reference added.