Ethanol Lock and Risk of Catheter Related Blood Stream Infection in Patients With Haemodialysis Catheter

Study Overview
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Brief Summary
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The aim of this study is to examine the effect of ethanol (70%) as lock-solution after hemodialysis on: The frequency of dialysis catheter-related bacteremia among patients under observation of potential complications Other complications of the use of hemodialysis-catheters eg. dysfunction of the catheter due to thrombosis.

Official Title
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Ethanol Lock and Risk of Catheter Related Blood Stream Infection in Patients With Haemodialysis Catheter

Conditions
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Hemodialysis Catheter-Associated Bacteremia, Hemodialysis Complication

Intervention / Treatment
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* Drug: Ethanol 70%
* Drug: Isotonic saline with heparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at or above 18 years. Currently recieving hemodialysis treatment with tunneled intravenous hemodialysis-catheter Written informed consent after verbal and written information is given. Exclusion Criteria: Pregnancy or breastfeeding Intolerance to ethanol or contraindications for the use of ethanol. Eg. possible interactions, former alcohol dependency. Earlier infections to current catheter (exit-site, tunnel-infection and catheter-related bloodstream infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control arm<br>Standard procedure of isotonic saline with heparin as lock-solution | Drug: Isotonic saline with heparin<br>* Standard procedure of isotonic saline used as lock-fluid after completed hemodialysis.<br>|
| Experimental: Intervention arm<br>3 mL of 70% ethanol as lock-solution | Drug: Ethanol 70%<br>* Once a week, the catheter will be closed with 3 mL ethanol 70% lock-solution after a completed hemodialysis. The fluid will stay in the catheter until next hemodialysis (ca. 48 hours). The fluid will be aspirated before the hemodialysis. Standard lock-solution of isotonic saline with heparin will be used for the remaining two hemodialysis procedures of the week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemodialysis catheter-related bacteremia |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hemodialysis catheter-related bacteremia | number per year | 2 years | 
| Time to exit-site infection | days | 2 years | 
| Time to removal of catheter due to infection | days | 2 years | 
| Complications eg. catheter-thrombosis and pulmonary embolus | number per year | 2 years | 
| Life quality | score of QOL questionaire | 2 years | 
| Economical costs | Cost af treatment and cost of complications per patient year compared | 2 years |