Clinical trial NCT02227329: Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition
Official title: Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition: A Prospective Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Catheter-Related Blood Stream Infections
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ryan Hurt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.