TerminatedPhase 1/2

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

Stopped: Publication of guidelines advising against the use of ethanol locks.

United States39 participantsStarted 2014-07

Plain-language summary

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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Catheter-Related Blood Stream Infections

Timeframe: 1 year

Trial details

NCT IDNCT02227329

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10

Results submitted2017-08-07

View on ClinicalTrials.gov More Catheter-related Bloodstream Infection (CRBSI) Nos trials