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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05953675
Enrollment
280
Registered
2023-07-20
Start date
2018-08-01
Completion date
2025-04-30
Last updated
2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Catheter-Associated Bacteremia, Hemodialysis Complication

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.

Interventions

DRUGEthanol 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.

DRUGIsotonic saline with heparin

Standard procedure of isotonic saline used as lock-fluid after completed hemodialysis.

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to hemodialysis catheter-related bacteremia2 years

Secondary

MeasureTime frameDescription
Time to exit-site infection2 yearsdays
Time to removal of catheter due to infection2 yearsdays
Incidence of hemodialysis catheter-related bacteremia2 yearsnumber per year
Life quality2 yearsscore of QOL questionaire
Economical costs2 yearsCost af treatment and cost of complications per patient year compared
Complications eg. catheter-thrombosis and pulmonary embolus2 yearsnumber per year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026