Catheter-related Bloodstream Infection (CRBSI) NosPhase 1/2ELTNCT02227329

Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition

A Phase 1/2 study testing Ethanol, Heparin Lock and Normal Saline in people with Catheter-related Bloodstream Infection (CRBSI) Nos and Bloodstream Infection Due to Central Venous Catheter, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Catheter-related Bloodstream Infection (CRBSI) Nos, Bloodstream Infection Due to Central Venous Catheter, Bloodstream Infection Due to Hickman Catheter
What is being tested?: Ethanol, Heparin Lock and Normal Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Jul 2014to Oct 2016
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Newly started on Home parenteral Nutrition and anticipated duration >3 months.
Not previously on Home Parenteral Nutrition.
Providing consent.
Patients with non-medicare insurance.
Patients with medicare insurance and a supplementary insurance.
Patients with single lumen Hickman® catheters.
No known alcohol addiction.

Who cannot join

Failure to provide consent
Patients with medicare insurance and no other supplemental private insurance
Patients with a catheter type other than a single lumen Hickman®
Patients who are on HPN for less than three months
Pregnant patients
Patients who have previous proven addiction and dependence to alcohol.
Patients lacking capacity to provide consent
Patients who are not be managed by HPN team at investigator's institution

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition: A Prospective Randomized Control Trial.

This study is being implemented to identify the role of prophylactic use of ethanol lock in adult patients on home parenteral nutrition (HPN). Central catheter related blood stream infection is a major complication in patients on HPN. The investigators hypothesize that the prophylactic use of ELT will decrease the number of catheter related blood stream infections compared to the control group. The investigators further hypothesize that with the introduction of prophylactic ELT, the number of infections will decrease.

Read the detailed description

Catheter-related bloodstream infection (CRBSI) is a serious complication for home parenteral nutrition (HPN) patients causing morbidity, mortality, and prolonged hospitalization. CRBSIs may also result in the need for central venous catheter (CVC) removal and replacement. Current literature supports the use of antibiotics locks in patients with repeated CRBSI. There is a growing concern about the increased risk of microbial resistance with the long term use antibiotic locks. Ethanol lock therapy (ELT) has broad spectrum coverage and includes gram negative bacteria, gram positive bacteria, atypical bacteria, and fungi. Compared with antibiotic and other solution locks, which have limitations, ELT has excellent broad-spectrum bactericidal and fungicidal killing action and poses no problems with development of resistance over time. There is a lack of a randomized controlled study to characterize the role of ELT in adult patients on HPN.

Conditions: Catheter-related Bloodstream Infection (CRBSI) Nos, Bloodstream Infection Due to Central Venous Catheter, Bloodstream Infection Due to Hickman Catheter
Being tested: Ethanol, Heparin Lock, Normal Saline
Keywords: Home Parenteral Nutrition, Infection Prevention, CRBSI, Ethanol Lock Therapy
Medical subject headings: Pyloric Stenosis, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EthanolDrug
Also called Alcohol lock, Ethanol (EtOH), ELT therapy
Prophylactic ELT will be administered at the time when the HPN is not being infused.
Heparin LockDrug
Also called Hep-Lock, Heparin
3 mL of 100 U/ml heparin
Normal SalineDrug
Also called N Saline, 0.9 N saline

Study groups in NCT02227329
Study group	Role	What they receive
Ethanol Lock and Normal Saline	Experimental	All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush. Receives: Drug: Ethanol; Drug: Normal Saline
Heparin and Normal Saline	Active comparator	All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care). Receives: Drug: Heparin Lock; Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Catheter-Related Blood Stream Infections
The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and >1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Oct 2016

First posted28 Aug 2014 (estimated)
Study startJul 2014
Primary completionOct 2016
Study completionOct 2016

Why it stopped: Publication of guidelines advising against the use of ethanol locks.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Catheter-related Bloodstream Infection (CRBSI) NosStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02227329
Sponsor's protocol ID: 13-007793
Acronym: ELT
Status last verified: Nov 2017
First submitted: 15 Aug 2014
Last updated: 12 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Salonen BR, Bonnes SL, Vallumsetla N, Varayil JE, Mundi MS, Hurt RT. A prospective double blind randomized controlled study on the use of ethanol locks in HPN patients. Clin Nutr. 2018 Aug;37(4):1181-1185. doi: 10.1016/j.clnu.2017.05.009. Epub 2017 May 17.
PubMed 28576557

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition: A Prospective Randomized Control Trial.
ClinicalTrials.gov ID: NCT02227329
Acronym / sponsor ID: ELT / 13-007793
Conditions: Catheter-related Bloodstream Infection (CRBSI) Nos, Bloodstream Infection Due to Central Venous Catheter, Bloodstream Infection Due to Hickman Catheter
Keywords: Home Parenteral Nutrition, Infection Prevention, CRBSI, Ethanol Lock Therapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Publication of guidelines advising against the use of ethanol locks.
Enrolment: 39 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: Jul 2014 (actual)
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 28 Aug 2014 (estimated)
Results: Posted 12 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ethanol Lock and Normal Saline	Experimental	Drug: Ethanol, Drug: Normal SalineAll patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
Heparin and Normal Saline	Active comparator	Drug: Heparin Lock, Drug: Normal SalineAll patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Newly started on Home parenteral Nutrition and anticipated duration >3 months.
Not previously on Home Parenteral Nutrition.
Providing consent.
Patients with non-medicare insurance.
Patients with medicare insurance and a supplementary insurance.

Key exclusion criteria (8 listed)

Failure to provide consent
Patients with medicare insurance and no other supplemental private insurance
Patients with a catheter type other than a single lumen Hickman®
Patients who are on HPN for less than three months
Pregnant patients

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
EthanolAlso: Alcohol lock, Ethanol (EtOH), ELT therapyProphylactic ELT will be administered at the time when the HPN is not being infused.	Drug	Ethanol Lock and Normal Saline
Heparin LockAlso: Hep-Lock, Heparin3 mL of 100 U/ml heparin	Drug	Heparin and Normal Saline
Normal SalineAlso: N Saline, 0.9 N saline	Drug	Ethanol Lock and Normal Saline, Heparin and Normal Saline

Primary outcome

Number of Catheter-Related Blood Stream Infections
Time frame: 1 year
The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and >1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter.

Results and safety

Results posted to the registry on 12 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ethanol Lock and Normal Saline	18	18
Heparin and Normal Saline	20	20

Primary outcome: Number of Catheter-Related Blood Stream Infections

Time frame: 1 year. Number. Unit: infections

Measure	Ethanol Lock and Normal Saline n = 18	Heparin and Normal Saline n = 20
Value	4	1

Ethanol Lock and Normal Saline vs Heparin and Normal Saline: p = 0.17, t-test, 2 sided

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ethanol Lock and Normal Saline	0 of 18 (0%)	4 of 18 (22.2%)	0 of 18
Heparin and Normal Saline	0 of 20 (0%)	1 of 20 (5%)	0 of 20

Limitations and caveats (from the sponsor): Due to European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines on chronic intestinal failure in adults advising against ELT, we conducted an interim analysis. The study was terminated early; further study would not change outcome.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28576557Salonen BR, Bonnes SL, Vallumsetla N, Varayil JE, Mundi MS, Hurt RT. A prospective double blind randomized controlled study on the use of ethanol locks in HPN patients. Clin Nutr. 2018 Aug;37(4):1181-1185. doi: 10.1016/j.clnu.2017.05.009. Epub 2017 May 17.

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.

Ryan Hurt, MD, PhD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 8 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 12 Dec 2017. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Catheter-Related Blood Stream Infections (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02227329, which also lists 1 linked publication.

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 12 Dec 2017.