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

NCT05953675 | Unknown

• 1 other identifier: REG-184-2017
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Catheter-Associated Bacteremia; Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

• Time to hemodialysis catheter-related bacteremia

  2 years

Secondary Outcomes (6)

• Incidence of hemodialysis catheter-related bacteremia

  2 years

• Time to exit-site infection

  2 years

• Time to removal of catheter due to infection

  2 years

• Complications eg. catheter-thrombosis and pulmonary embolus

  2 years

• Life quality

  2 years

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Standard procedure of isotonic saline with heparin as lock-solution

Drug: Isotonic saline with heparin

Intervention arm

EXPERIMENTAL

3 mL of 70% ethanol as lock-solution

Drug: Ethanol 70%

Interventions

Ethanol 70% 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.

Intervention arm

Isotonic saline with heparin DRUG

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

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Interventions

Sodium Chloride; Heparin

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Lothar Wiese, MD,PhD

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: July 20, 2023
• Study Start: August 1, 2018
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)