Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02227329
Status:
TERMINATED
Last Update Posted:
2017-12-12
First Post:
2014-08-15
Brief Title:
Prophylactic Ethanol Lock Therapy ELT in Patients on Home Parenteral Nutrition
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Prophylactic Ethanol Lock Therapy ELT in Patients on Home Parenteral Nutrition A Prospective Randomized Control Trial
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Publication of guidelines advising against the use of ethanol locks
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELT
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None