Preemptive Ethanol Lock Therapy in Pediatric Bloodstream Infection
Condition: Leukemia; Lymphoma; Blood Disorders; Solid Tumors
MeSH terms: Sepsis; Hematologic Diseases
Intervention: Ethanol lock therapy (ELT)
Intervention description: 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.
Intervention MeSH terms: Ethanol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 6 Months
Maximum age: 21 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All children up to 21 years of age, with central catheters (any type) that develop
             symptoms and are admitted to CHM with an underlying H/O/BMT diagnosis for individual
             episodes of suspected or proven CRI of the blood, including rule out sepsis, will be
             screened for potential participation in this study.

          -  Individual CRI episodes in the same patient will be defined as a distinct central
             catheter associated blood stream infection if separated by greater than 28 days from
             prior ELT procedure and caused by a different organism identified on culture than the
             prior central catheter associated blood stream infection episode.

          -  Participants meeting study enrollment criteria will be offered participation and must
             have parental full informed consent, adolescent assent and young child verbal assent
             prior to enrollment as applicable.

        Exclusion Criteria:

          -  Children with documented allergy to ethanol or alcohol will be excluded. Blood
             cultures from patients that are reported positive for pathogen growth within 12 hours
             from the time they are obtained will be excluded from the study.

          -  Any patient at CHM with an infected central catheter and with another indwelling
             foreign body that communicates directly with the bloodstream, of which infection or
             colonization could not be excluded directly, will also be excluded from the study
             (i.e. Left Ventricular Assist Device) as it will not be possible to assess
             sterilization of the central catheter.

          -  Any patient with endocarditis or presumed endovascular infection will also be
             excluded.

          -  Any patient deemed critically ill or unstable, upon admission or during the early
             treatment course, in which case the treating clinician(s) feel that immediate line
             removal is potentially life-saving will be excluded from the study.