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

July 12, 2023 updated by: Zealand University Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control arm
Standard procedure of isotonic saline with heparin as lock-solution
Drug: Isotonic saline with heparin
Standard procedure of isotonic saline used as lock-fluid after completed hemodialysis.
Experimental: Intervention arm
3 mL of 70% ethanol as lock-solution
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Lothar Wiese, MD,PhD, Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 21, 2020

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-184-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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