Preemptive Ethanol Lock Therapy in Pediatric Bloodstream Infection
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
The study team will compare hospital length of stay (LOS) and attributable length of stay
(ALOS, the LOS attributable to CRI), in a randomized, un-blinded prospective trial utilizing
short-dwell ethanol-lock therapy (ELT) (4 hours to 24 hour dwell times per day, repeated for
up to 72 hours) placed within 24 - 36 hours of admission(Group 1, Preemptive ELT) versus ELT
placed at the time of first positive blood culture report (Group 2, Rescue ELT (Standard of
Care ). ELT will be given in both groups, in combination with systemic antibiotics, for the
treatment of CRI (suspected or proven) of the blood in children with central catheters.
Participants will be enrolled from patients with hematologic/oncologic disorders and bone
marrow or hematopoetic stem cell transplants (BMT) admitted for care to Children's Hospital
of Michigan (CHM), a tertiary care pediatric hospital in Detroit, Michigan. ALOS will be
defined as the number of hospital days between first symptoms of Catheter-related infection
(CRI) (or date of admission for those admitted with symptoms) and first negative blood
culture.
Study Hypothesis: The main hypothesis is that the short-dwell ethanol-lock therapy, defined
above, placed within 24 - 36 hours of symptoms/admission (Arm 1) versus ELT placement at the
time of first positive blood culture report (Arm 2), with concomitant systemic antibiotics,
for the treatment of CRI (suspected or proven) of the blood in children with central
catheters in the H/O/BMT population will have shorter hospital length of stay (LOS) and
attributable LOS (ALOS) and therefore lower hospital costs.