Catheter-Related InfectionsNCT02890875
Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections
A study testing Ethanol lock and Heparin lock in people with Catheter-Related Infections, run by Stanford University at 1 site in United States.
Trial summary
Patients on long-term parenteral nutrition (PN) are at high risk for central line-associated bloodstream infections (CLABSI). This study evaluates the efficacy and safety of ethanol lock therapy for CLABSI prophylaxis in adult patients on PN. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Catheter-Related Infections
- What is being tested?
- Ethanol lock and Heparin lock
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Mar 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (ages 18-80) on PN with silicone-based central venous catheters
Who cannot join
- Weight ≤ 50 kg
- Allergy/hypersensitivity/intolerance to ethanol or heparin
- Pregnancy or breastfeeding
- Patient taking metronidazole, disulfiram, or isoniazid
- History of alcohol abuse
- History of heparin-induced thrombocytopenia (HIT) or have an active hypocoagulable state
Trial locations and contacts
1 site in 1 country.
About this study
Patients on long-term parenteral nutrition (PN) are at high risk for central line-associated bloodstream infections (CLABSI). This study evaluates the efficacy and safety of ethanol lock therapy for CLABSI prophylaxis in adult patients on PN.
- Conditions
- Catheter-Related Infections
- Being tested
- Ethanol lock, Heparin lock
- Keywords
- ethanol lock, parenteral nutrition
- Medical subject headings
- Catheter-Related Infections, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol lockOther
Heparin lockOther
| Study group | Role | What they receive |
|---|---|---|
| Ethanol lock | Active comparator | 70% ethanol Receives: Other: Ethanol lock |
| Heparin lock | Active comparator | Heparinized saline (100 U/mL) Receives: Other: Heparin lock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central line-associated bloodstream infection
Measured: 12 months
Secondary outcomes (4)
Hospitalization
Measured: 12 months
SIRS/sepsis
Measured: 12 months
Catheter-related complication
Measured: 12 months
New self-reported symptoms
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkeley Limketkai, Stanford University
- Investigators
- Berkeley Limketkai, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890875
- Sponsor's protocol ID
- 38195
- Status last verified
- Apr 2019
- First submitted
- 29 Aug 2016
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections
- ClinicalTrials.gov ID
- NCT02890875
- Acronym / sponsor ID
- 38195
- Conditions
- Catheter-Related Infections
- Keywords
- ethanol lock, parenteral nutrition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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.
Patients on long-term parenteral nutrition (PN) are at high risk for central line-associated bloodstream infections (CLABSI). This study evaluates the efficacy and safety of ethanol lock therapy for CLABSI prophylaxis in adult patients on PN.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethanol lock | Active comparator | Other: Ethanol lock70% ethanol |
| Heparin lock | Active comparator | Other: Heparin lockHeparinized saline (100 U/mL) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (ages 18-80) on PN with silicone-based central venous catheters
Key exclusion criteria (6 listed)
- Weight ≤ 50 kg
- Allergy/hypersensitivity/intolerance to ethanol or heparin
- Pregnancy or breastfeeding
- Patient taking metronidazole, disulfiram, or isoniazid
- History of alcohol abuse
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 lock | Other | Ethanol lock |
| Heparin lock | Other | Heparin lock |
Primary outcome
Central line-associated bloodstream infection
Time frame: 12 months
4 secondary outcomes
Hospitalization
Time frame: 12 months
SIRS/sepsis
Time frame: 12 months
Catheter-related complication
Time frame: 12 months
New self-reported symptoms
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
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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.
Berkeley Limketkai, MD principal investigator
Stanford University
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 lock and Heparin lock in people with Catheter-Related Infections, run by Stanford University at 1 site in United States.
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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 2 May 2019. 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 United States. 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?
The study was stopped early (reason given: Low recruitment). 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?
Central line-associated bloodstream infection (time frame: 12 months). 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 2 May 2019.