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

November 13, 2017 updated by: Ryan T. Hurt, M.D., Ph.D., Mayo Clinic

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ethanol Lock and Normal Saline
All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
Drug: Normal Saline
Other Names:
  • N Saline
  • 0.9 N saline
Drug: Ethanol
Prophylactic ELT will be administered at the time when the HPN is not being infused.
Other Names:
  • Alcohol lock
  • Ethanol (EtOH)
  • ELT therapy
Active Comparator: Heparin and Normal Saline
All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).
Drug: Normal Saline
Other Names:
  • N Saline
  • 0.9 N saline
Drug: Heparin Lock
3 mL of 100 U/ml heparin
Other Names:
  • Heparin
  • Hep-Lock

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Ryan Hurt, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

August 15, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 28, 2014

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-007793

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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