drugset / Trial / NCT02227329

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

NCT02227329 ↗

Phase 1/2 Terminated 39 enrolled Mayo Clinic
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2014-07
Primary completion
2016-10
Completion
2016-10

Outcome

Missed primary endpoint

Stopped: “Publication of guidelines advising against the use of ethanol locks.”

paper Four patients in the ELT group and one patient in the control arm had a CRBSI (p = 0.17). PMID 28576557 ↗

paper This study did not show improvement in the rate of CRBSI with ELT in all patients started on HPN. PMID 28576557 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ethanol Other / unclassified 3 ml Other
Comparator Heparin Other / unclassified 3 ml Other
Background sodium chloride Unknown — Other

Indications

No indication recorded.