Cathasept for prevention of catheter colonisatio

Completed

• Conditions: Microbial colonisation of tunnelled haemodialysis catheters; Infections and Infestations

• Registration Number: ISRCTN15554338
• Lead Sponsor: Tyco Healthcare Group LP d/b/a Covidien (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-02
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Incidence rate of CRBSI<br>2. Number of dialysis sessions where the prescribed blood flow was achieved<br>3. Incidence rate of interventions to improve catheter patency including intra-catheter lock or infusion of thrombolytic agents<br>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).