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| Name | Class |
|---|---|
| Blue Cross Blue Shield of Michigan Foundation | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-emptive Ethanol Lock Therapy Group | Experimental | Participants receive ethanol lock before blood cultures grow germ |
|
| Standard Ethanol Lock Therapy Group | Active Comparator | Participants receive ethanol lock if and only after blood cultures grow germ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter Sterilization | Number of Catheters sterilized with interventions | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
| Catheter Salvage | Number of Infected catheters (which achieved sterilization) with salvage for at least 14 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric J McGrath, MD | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21622689 | Background | 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. | |
| 24807976 | Background |
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3 enrolled participants were removed from the study/analysis for failure to meet final enrollment criteria. Patient participants could be re-enrolled in the study more than once if their infection episodes (cases) were separated by at least 28 days.
135 episodes screened, but only 36 initially met enrollment criteria. 27 unique patients were enrolled for 33 episodes (6 patients enrolled twice) of possible catheter infection.
| ID | Title | Description |
|---|---|---|
| FG000 | Pre-emptive Ethanol Lock Therapy Group | Study intervention group (Arm 1). Received Early Ethanol Lock Therapy before blood culture results were reported as positive or negative. |
| FG001 | Standard Ethanol Lock Therapy Group | Standard of Care Group (Arm 2) that received Ethanol Lock Therapy if and only if the blood culture was positive for growth of an organism. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-emptive Ethanol Lock Therapy Group | Study intervention group (Arm 1). Received Early Ethanol Lock Therapy before blood culture results were reported as positive or negative. |
| BG001 | Standard Ethanol Lock Therapy Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group. | Posted | Mean | Standard Deviation | HOURS | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | Catheter Infection Episodes (cases) | Catheter Infection Episodes (cases) |
|
Each participant was assessed for Adverse Events for up to 30 days post ELT receipt. (1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.)
Elevation of ALT, AST from baseline; CVC line breakage, malfuntion, or thrombosis; Reinfection of line within 14 days after line.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Study Arm, given pre-emptive ELT | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric McGrath, MD | Wayne State University School of Medicine - Children's Hosp. of Michigan | 313-745-5862 | emcgrath@med.wayne.edu |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D014867 | Water |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 |
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|
|
| 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 | Number of Adverse events per episode of distinct catheter infection that are thought to be related to the actual study intervention, namely timing of ethanol lock placement, will be reviewed and reported for each individual infection episode/admission. | 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 | Number of Re-Infected of salvaged catheters with same or new organism(s) within 28 days of prior CRI/ELT | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks but for up to 1 month total |
| 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. |
| 23906245 | 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. |
| 28664750 | Result | 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. |
Standard of Care Group (Arm 2) that received Ethanol Lock Therapy if and only if the blood culture was positive for growth of an organism.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Attributable Length of Stay (ALOS) in 14 Confirmed Catheter Related Infection Cases | TIME FROM FIRST POSITIVE TO FIRST NEGATIVE BLOOD CULTURE | 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group. | Posted | Mean | Standard Deviation | HOURS | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | Catheter Infection Episodes (cases) | Catheter Infection Episodes (cases) |
|
|
|
| Primary | Hospital COSTS in 14 Confirmed Catheter Related Infection Cases | Hospital COSTS | 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group. | Posted | Mean | Standard Deviation | USD $ | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | Catheters | Catheters |
|
|
|
| Secondary | Catheter Sterilization | Number of Catheters sterilized with interventions | 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group. | Posted | Number | Catheters | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | Catheters | Catheters |
|
|
|
| Secondary | Catheter Salvage | Number of Infected catheters (which achieved sterilization) with salvage for at least 14 days. | 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group. | Posted | Number | Catheters | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | Catheters | Catheters |
|
|
|
| Secondary | Number of Adverse Events Per Episode of Catheter Infection | Number of Adverse events per episode of distinct catheter infection that are thought to be related to the actual study intervention, namely timing of ethanol lock placement, will be reviewed and reported for each individual infection episode/admission. | 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group. | Posted | Number | Adverse Events | 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 | Catheter Infection Episodes (cases) | Catheter Infection Episodes (cases) |
|
|
|
| Secondary | Re-infection | Number of Re-Infected of salvaged catheters with same or new organism(s) within 28 days of prior CRI/ELT | 1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group. | Posted | Number | Catheters | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks but for up to 1 month total | Catheters | Catheters |
|
|
|
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Arm 2 | Study Arm, given standard of care | 0 | 8 | 0 | 8 | 0 | 8 |
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| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |