NCT02227329

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Ethanol	Prophylactic ELT will be administered at the time when the HPN is not being infused.
DRUG	Heparin Lock	3 mL of 100 U/ml heparin
DRUG	Normal Saline

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-08-28
• Last updated: 2017-12-12
• Results posted: 2017-12-12

Locations

1 site across 1 country: United States