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

Sponsor

Zealand University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05953675

Collaborator

(none)

280

Enrollment

Location

Arms

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis Catheter-Associated Bacteremia Hemodialysis Complication	Drug: Ethanol 70% Drug: Isotonic saline with heparin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Time to hemodialysis catheter-related bacteremia [2 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zealand University Hospital	Roskilde		Denmark	4000

Sponsors and Collaborators

Zealand University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zealand University Hospital

ClinicalTrials.gov Identifier:

NCT05953675

Other Study ID Numbers:

REG-184-2017

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 20, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2023