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

Mayo Clinic

Status and phase: Terminated; Phase 2; Phase 1

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

Treatments: Drug: Heparin Lock; Drug: Ethanol; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02227329

13-007793

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 2 patient groups

Ethanol Lock and Normal Saline

Experimental group

Description:

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

Treatment:

Drug: Normal Saline

Drug: Ethanol

Heparin and Normal Saline

Active Comparator group

Description:

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

Treatment:

Drug: Normal Saline

Drug: Heparin Lock