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

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ClinicalTrials.gov Identifier: NCT02227329
Recruitment Status : Terminated (Publication of guidelines advising against the use of ethanol locks.)
First Posted : August 28, 2014
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Ryan T. Hurt, M.D., Ph.D., Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Catheter-related Bloodstream Infection (CRBSI) Nos Bloodstream Infection Due to Central Venous Catheter Bloodstream Infection Due to Hickman Catheter Drug: Ethanol Drug: Heparin Lock Drug: Normal Saline Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition: A Prospective Randomized Control Trial.
Actual Study Start Date : July 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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: Ethanol
Prophylactic ELT will be administered at the time when the HPN is not being infused.
Other Names:
  • Alcohol lock
  • Ethanol (EtOH)
  • ELT therapy

Drug: Normal Saline
Other Names:
  • N Saline
  • 0.9 N saline
Active Comparator: Heparin and Normal Saline
All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).
 Drug: Heparin Lock
3 mL of 100 U/ml heparin
Other Names:
  • Hep-Lock
  • Heparin

Drug: Normal Saline
Other Names:
  • N Saline
  • 0.9 N saline


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227329


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Ryan Hurt, MD, PhD Mayo Clinic
More Information
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Publications of Results:

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Responsible Party: Ryan T. Hurt, M.D., Ph.D., Associate Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02227329    
Other Study ID Numbers: 13-007793
First Posted: August 28, 2014    Key Record Dates
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017
Last Verified: November 2017
Keywords provided by Ryan T. Hurt, M.D., Ph.D., Mayo Clinic:
Home Parenteral Nutrition
Infection Prevention
CRBSI
Ethanol Lock Therapy
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Sepsis
Disease Attributes
Pathologic Processes
Systemic Inflammatory Response Syndrome
Inflammation
Ethanol
Heparin
 Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs