Hemodialysis Catheter-Associated BacteremiaNCT05953675
Ethanol Lock and Risk of Catheter Related Blood Stream Infection in Patients With Haemodialysis Catheter
A study testing Ethanol 70% and Isotonic saline with heparin in people with Hemodialysis Catheter-Associated Bacteremia and Hemodialysis Complication, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Catheter-Associated Bacteremia, Hemodialysis Complication
- What is being tested?
- Ethanol 70% and Isotonic saline with heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2018to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Ethanol 70%, Isotonic saline with heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Isotonic saline with heparinDrug
Standard procedure of isotonic saline used as lock-fluid after completed hemodialysis.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Standard procedure of isotonic saline with heparin as lock-solution Receives: Drug: Isotonic saline with heparin |
| Intervention arm | Experimental | 3 mL of 70% ethanol as lock-solution Receives: Drug: Ethanol 70% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hemodialysis catheter-related bacteremia
Measured: 2 years
Secondary outcomes (6)
Incidence of hemodialysis catheter-related bacteremia
number per year
Measured: 2 years
Time to exit-site infection
days
Measured: 2 years
Time to removal of catheter due to infection
days
Measured: 2 years
Complications eg. catheter-thrombosis and pulmonary embolus
number per year
Measured: 2 years
Life quality
score of QOL questionaire
Measured: 2 years
Economical costs
Cost af treatment and cost of complications per patient year compared
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Aug 2018
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis Catheter-Associated BacteremiaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lothar Wiese, MD,PhD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953675
- Sponsor's protocol ID
- REG-184-2017
- Status last verified
- Jul 2023
- First submitted
- 21 Mar 2020
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethanol Lock and Risk of Catheter Related Blood Stream Infection in Patients With Haemodialysis Catheter
- ClinicalTrials.gov ID
- NCT05953675
- Acronym / sponsor ID
- REG-184-2017
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Drug: Isotonic saline with heparinStandard procedure of isotonic saline with heparin as lock-solution |
| Intervention arm | Experimental | Drug: Ethanol 70%3 mL of 70% ethanol as lock-solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Intervention arm |
| Isotonic saline with heparinStandard procedure of isotonic saline used as lock-fluid after completed hemodialysis. | Drug | Control arm |
Primary outcome
Time to hemodialysis catheter-related bacteremia
Time frame: 2 years
6 secondary outcomes
Incidence of hemodialysis catheter-related bacteremia
Time frame: 2 years
Time to exit-site infection
Time frame: 2 years
Time to removal of catheter due to infection
Time frame: 2 years
Complications eg. catheter-thrombosis and pulmonary embolus
Time frame: 2 years
Life quality
Time frame: 2 years
Economical costs
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lothar Wiese, MD,PhD principal investigator
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol 70% and Isotonic saline with heparin in people with Hemodialysis Catheter-Associated Bacteremia and Hemodialysis Complication, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to hemodialysis catheter-related bacteremia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.