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

Phase 1

Terminated

• Conditions: Bloodstream Infection Due to Central Venous Catheter; Bloodstream Infection Due to Hickman Catheter; Catheter-related Bloodstream Infection (CRBSI) Nos
• Interventions: Drug: Heparin Lock; Drug: Ethanol; Drug: Normal Saline

• Registration Number: NCT02227329
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-15
• Study First Submitted QC: 2014-08-27
• Study First Posted: 2014-08-28
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-08-07
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-13
• Last Update Submitted: 2017-11-13
• Results First Posted: 2017-12-12
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin and Normal Saline	Normal Saline	All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).
Ethanol Lock and Normal Saline	Normal Saline	All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
Heparin and Normal Saline	Heparin Lock	All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).
Ethanol Lock and Normal Saline	Ethanol	All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.

Primary Outcome Measures

Name	Time	Method
Number of Catheter-Related Blood Stream Infections	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States