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

NCT ID: NCT05953675

Last Updated: 2023-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2025-04-30

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.

Detailed Description

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Conditions

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Hemodialysis Catheter-Associated Bacteremia Hemodialysis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control arm

Standard procedure of isotonic saline with heparin as lock-solution

Group Type ACTIVE_COMPARATOR

Isotonic saline with heparin

Intervention Type DRUG

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

Intervention arm

3 mL of 70% ethanol as lock-solution

Group Type EXPERIMENTAL

Ethanol 70%

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Isotonic saline with heparin

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lothar Wiese, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Locations

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Zealand University Hospital

Roskilde, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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REG-184-2017

Identifier Type: -

Identifier Source: org_study_id

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