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

Not Applicable

Active, not recruiting

• Conditions: Hemodialysis Complication; Hemodialysis Catheter-Associated Bacteremia
• Interventions: Drug: Isotonic saline with heparin; Drug: Ethanol 70%

• Registration Number: NCT05953675
• Lead Sponsor: Zealand University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2020-03-21
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-12
• Last Update Submitted: 2023-07-12
• Study First Posted: 2023-07-20
• Last Update Posted: 2023-07-20
• Primary Completion: 2024-12
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Isotonic saline with heparin	Standard procedure of isotonic saline with heparin as lock-solution
Intervention arm	Ethanol 70%	3 mL of 70% ethanol as lock-solution

Primary Outcome Measures

Name	Time	Method
Time to hemodialysis catheter-related bacteremia	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Roskilde, Denmark