Preemptive Ethanol Lock Therapy in Pediatric Bloodstream Infection

NCT02095951 | Completed Phase 4 Results DMC

• 1 other identifier: 2024.11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia; Lymphoma; Blood Disorders; Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Length of Stay (LOS) in Those With 14 Confirmed Catheter Related Infection Cases

  A primary endpoint of this study is length of stay (LOS) per catheter infection episode/admission

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Attributable Length of Stay (ALOS) in 14 Confirmed Catheter Related Infection Cases

  TIME FROM FIRST POSITIVE TO FIRST NEGATIVE BLOOD CULTURE

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Hospital COSTS in 14 Confirmed Catheter Related Infection Cases

  Hospital COSTS

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes (4)

• Catheter Sterilization

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Catheter Salvage

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Number of Adverse Events Per Episode of Catheter Infection

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks but up to 1 month post the last ethanol dose administration

• Re-infection

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks but for up to 1 month total

Study Arms (2)

Pre-emptive Ethanol Lock Therapy Group

EXPERIMENTAL

Participants receive ethanol lock before blood cultures grow germ

Drug: Ethanol lock therapy (ELT)

Standard Ethanol Lock Therapy Group

ACTIVE COMPARATOR

Participants receive ethanol lock if and only after blood cultures grow germ

Drug: Ethanol lock therapy (ELT)

Interventions

Ethanol lock therapy (ELT) DRUG

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.

Also known as: 70% Ethanol in water

Pre-emptive Ethanol Lock Therapy Group; Standard Ethanol Lock Therapy Group

Eligibility Criteria

• Age: 6 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Michigan: lead
• Blue Cross Blue Shield of Michigan Foundation: collaborator

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Related Publications (4)

• McGrath EJ, Salloum R, Chen X, Jiang Y, Boldt-MacDonald K, Becker C, Chu R, Ang JY. Short-dwell ethanol lock therapy in children is associated with increased clearance of central line-associated bloodstream infections. Clin Pediatr (Phila). 2011 Oct;50(10):943-51. doi: 10.1177/0009922811409568. Epub 2011 May 27.

  PMID: 21622689 BACKGROUND

• Chaudhary M, Bilal MF, Du W, Chu R, Rajpurkar M, McGrath EJ. The impact of ethanol lock therapy on length of stay and catheter salvage in pediatric catheter-associated bloodstream infection. Clin Pediatr (Phila). 2014 Oct;53(11):1069-76. doi: 10.1177/0009922814533591. Epub 2014 May 7.

  PMID: 24807976 BACKGROUND

• Rajpurkar M, McGrath E, Joyce J, Boldt-MacDonald K, Chitlur M, Lusher J. Therapeutic and prophylactic ethanol lock therapy in patients with bleeding disorders. Haemophilia. 2014 Jan;20(1):52-7. doi: 10.1111/hae.12241. Epub 2013 Aug 1.

  PMID: 23906245 BACKGROUND

• McGrath E, Du W, Rajpurkar M. Preemptive Ethanol Lock Therapy in Pediatric Hematology/Oncology Patients With Catheter-Associated Bloodstream Infection: Impact on Length of Stay, Cost, and Catheter Salvage. Clin Pediatr (Phila). 2018 Mar;57(3):285-293. doi: 10.1177/0009922817717327. Epub 2017 Jun 30.

  PMID: 28664750 RESULT

MeSH Terms

Conditions

Leukemia; Lymphoma; Hematologic Diseases

Interventions

Ethanol; Water

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Eric McGrath, MD
• Organization: Wayne State University School of Medicine - Children's Hosp. of Michigan

emcgrath@med.wayne.edu

313-745-5862

Study Officials

• Eric J McGrath, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics - Clinical

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 26, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 19, 2018
• Results First Posted: December 19, 2018

Record last verified: 2018-08

Locations

US (1)