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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Drug: Ethanol
* Drug: Heparin Lock
* Drug: Normal Saline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Home Parenteral Nutrition, Infection Prevention, CRBSI, Ethanol Lock Therapy