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NCT05953675 Clinical Trial

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

Hemodialysis Complication Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05953675
Other study ID # REG-184-2017
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date April 2025

Study information
Verified date July 2023
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 280
Est. completion date April 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Ethanol 70%
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.
• Isotonic saline with heparin
Standard procedure of isotonic saline used as lock-fluid after completed hemodialysis.

Locations
Country Name City State
Denmark Zealand University Hospital Roskilde

Sponsors (1)
Lead Sponsor Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

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