Overview

This trial is active, not recruiting.

Conditions catheter-related bloodstream infection (crbsi) nos, catheter-related bloodstream infection due to central venous catheter, bloodstream infection due to hickman catheter
Treatments ethanol, heparin lock, normal saline
Phase phase 1/phase 2
Sponsor Mayo Clinic
Start date July 2014
End date October 2016
Trial size 39 participants
Trial identifier NCT02227329, 13-007793

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. This will improve the quality of life (assessed using Questionnaire) in HPN patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
ethanol Alcohol lock
Prophylactic ELT will be administered at the time when the HPN is not being infused.
normal saline N Saline
(Active Comparator)
All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).
heparin lock Hep-Lock
normal saline N Saline

Primary Outcomes

Measure
The number of catheter related blood stream infections
time frame: 1 year

Secondary Outcomes

Measure
Quality of life assessment
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition: A Prospective Randomized Control Trial.
Principal investigator Ryan Hurt, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.