Preemptive Ethanol Lock Therapy in Pediatric Bloodstream Infection
Condition: Leukemia; Lymphoma; Blood Disorders; Solid Tumors
MeSH terms: Sepsis; Hematologic Diseases
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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 Catheter-related Infection (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 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 CRI
      (or date of admission for those admitted with symptoms) and first negative blood culture.

      Aim 1: Compare two different treatment regimens for CRI using ELT (the preemptive ELT vs.
      standard of care) by way of a prospective, randomized, two-arm study.

      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.

      Aim 2: Compare sterilization rate of the infected intravascular device after ethanol-lock
      therapy (as defined by a negative blood culture obtained from the infected catheter 24 - 72
      hours after ELT) and central catheter salvage rate after CRI using ELT in the two study arms.
      If the central catheter is salvaged for further clinical use, recurrence of infection with
      the same organism (re-infection) of the central catheter for 28 days from date of first ELT
      procedure will also be assessed.

      Aim 3: Assess tolerability and adverse effects of the ELT (safety).

      Aim 4: Perform sub-group analysis on the BSI episodes meeting National Healthcare Safety
      Network (NHSN) criteria for laboratory confirmed central line associated BSI (CLABSI) into
      the three categories of Criteria 1, 2 or 3 within the pediatric
    

Intervention name(s): Ethanol lock therapy (ELT)
Intervention type(s): Drug
Intervention description(s): Participants will be randomized to receive early (preemptive) ELT (after 12 hours from time blood culture drawn, but before blood culture positive, R/O sepsis) with systemic antimicrobials versus standard ELT (placed in catheter when blood culture is positive for growth of a germ) with systemic antimicrobials.
Other intervention name(s): 70% Ethanol in water
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment