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

Primary Purpose

Catheter-related Bloodstream Infection (CRBSI) Nos, Bloodstream Infection Due to Central Venous Catheter, Bloodstream Infection Due to Hickman Catheter

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ethanol
Heparin Lock
Normal Saline
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter-related Bloodstream Infection (CRBSI) Nos focused on measuring Home Parenteral Nutrition, Infection Prevention, CRBSI, Ethanol Lock Therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ethanol Lock and Normal Saline

Heparin and Normal Saline

Arm Description

All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.

All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 15, 2014
Last Updated
November 13, 2017
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02227329
Brief Title
Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition
Acronym
ELT
Official Title
Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition: A Prospective Randomized Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Publication of guidelines advising against the use of ethanol locks.
Study Start Date
July 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ethanol Lock and Normal Saline
Arm Type
Experimental
Arm Description
All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
Arm Title
Heparin and Normal Saline
Arm Type
Active Comparator
Arm Description
All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).
Intervention Type
Drug
Intervention Name(s)
Ethanol
Other Intervention Name(s)
Alcohol lock, Ethanol (EtOH), ELT therapy
Intervention Description
Prophylactic ELT will be administered at the time when the HPN is not being infused.
Intervention Type
Drug
Intervention Name(s)
Heparin Lock
Other Intervention Name(s)
Hep-Lock, Heparin
Intervention Description
3 mL of 100 U/ml heparin
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
N Saline, 0.9 N saline
Primary Outcome Measure Information:
Title
Number of Catheter-Related Blood Stream Infections
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Hurt, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28576557
Citation
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.
Results Reference
result

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

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