Back to resultsEthanol Lock and Risk of Catheter Related Blood Stream Infection in Patients With Haemodialysis Catheter
Primary Purpose
Hemodialysis Catheter-Associated Bacteremia, Hemodialysis Complication
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ethanol 70%
Isotonic saline with heparin
Sponsored by
About this trial
This is an interventional prevention trial for Hemodialysis Catheter-Associated Bacteremia
Eligibility Criteria
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
Sites / Locations
- Zealand University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control arm
Intervention arm
Arm Description
Standard procedure of isotonic saline with heparin as lock-solution
3 mL of 70% ethanol as lock-solution
Outcomes
Primary Outcome Measures
Time to hemodialysis catheter-related bacteremia
Secondary Outcome Measures
Incidence of hemodialysis catheter-related bacteremia
number per year
Time to exit-site infection
days
Time to removal of catheter due to infection
days
Complications eg. catheter-thrombosis and pulmonary embolus
number per year
Life quality
score of QOL questionaire
Economical costs
Cost af treatment and cost of complications per patient year compared
Full Information
NCT ID
NCT05953675
First Posted
March 21, 2020
Last Updated
July 12, 2023
Sponsor
Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05953675
Brief Title
Ethanol Lock and Risk of Catheter Related Blood Stream Infection in Patients With Haemodialysis Catheter
Official Title
Ethanol Lock and Risk of Catheter Related Blood Stream Infection in Patients With Haemodialysis Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Catheter-Associated Bacteremia, Hemodialysis Complication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Standard procedure of isotonic saline with heparin as lock-solution
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
3 mL of 70% ethanol as lock-solution
Intervention Type
Drug
Intervention Name(s)
Ethanol 70%
Intervention Description
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
Intervention Name(s)
Isotonic saline with heparin
Intervention Description
Standard procedure of isotonic saline used as lock-fluid after completed hemodialysis.
Primary Outcome Measure Information:
Title
Time to hemodialysis catheter-related bacteremia
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Incidence of hemodialysis catheter-related bacteremia
Description
number per year
Time Frame
2 years
Title
Time to exit-site infection
Description
days
Time Frame
2 years
Title
Time to removal of catheter due to infection
Description
days
Time Frame
2 years
Title
Complications eg. catheter-thrombosis and pulmonary embolus
Description
number per year
Time Frame
2 years
Title
Life quality
Description
score of QOL questionaire
Time Frame
2 years
Title
Economical costs
Description
Cost af treatment and cost of complications per patient year compared
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lothar Wiese, MD,PhD
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zealand University Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ethanol Lock and Risk of Catheter Related Blood Stream Infection in Patients With Haemodialysis Catheter
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