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| ID | Type | Description | Link |
|---|---|---|---|
| OCR18899 | Other Identifier | University of Florida |
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The purpose of this research study is to compare the current standard of care for prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of Cefazolin during pediatric spinal surgery.
Determine the skeletal muscle and adipose tissue disposition of prophylactic Cefazolin using microdialysis sampling in a cohort of patients diagnosed with idiopathic scoliosis undergoing posterior spinal fusion (PSF) for administration of Cefazolin by either continuous infusion or intermittent bolus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Regimen Group | Active Comparator | The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted. |
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| Second Regimen Group | Active Comparator | The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bolus dose of Cefazolin | Drug | Mode of Cefazolin administration will be a intermittent bolus |
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| Measure | Description | Time Frame |
|---|---|---|
| Unbound Cefazolin Concentration in Skeletal Muscle | First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle | Changes from baseline (pre-op) up to end of surgical procedure |
| Unbound Cefazolin in Adipose Tissue | First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of adipose tissue | Changes from baseline (pre-op) up to end of surgical procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Seubert, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | First Regimen Group | The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted. Bolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus Paraspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle Subcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region |
| FG001 | Second Regimen Group | The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously. Continuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip Paraspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle Subcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One subject was withdrawn from each group and not included in the analysis due to insufficient data.
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| ID | Title | Description |
|---|---|---|
| BG000 | First Regimen Group | The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted. Bolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus Paraspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle Subcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Unbound Cefazolin Concentration in Skeletal Muscle | First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle | Posted | Median | 75% Confidence Interval | µg/ml/kg | Changes from baseline (pre-op) up to end of surgical procedure |
|
1 day
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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 | First Regimen Group | The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted. Bolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus Paraspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle Subcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christoph Seubert, MD | University of Florida | 352-273-8960 | cseubert@anest.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2018 | Jun 20, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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Simple randomization will be used with each patient has probability 0.5 to be assigned in Group I or Group II. Computer program will generate a uniform random variable between 0 to 1, with subject assigned to Group I if the value is less than 0.5 and assigned to Group II if the value is greater than 0.5.
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| Continuous Cefazolin drip | Drug | Mode of Cefazolin administration will be a continuous drip |
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| Paraspinal muscle microdialysis catheters | Device | Two dialysis probes will be inserted into a paraspinal muscle |
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| Subcutaneous microdialysis catheters | Device | Two dialysis probes will be inserted into a paraspinal subcutaneous region |
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| BG001 | Second Regimen Group | The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously. Continuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip Paraspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle Subcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Second Regimen Group | The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously. Continuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip Paraspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle Subcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region |
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| Primary | Unbound Cefazolin in Adipose Tissue | First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of adipose tissue | Posted | Median | 75% Confidence Interval | µg/ml/kg | Changes from baseline (pre-op) up to end of surgical procedure |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Second Regimen Group | The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously. Continuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip Paraspinal muscle microdialysis catheters: Two dialysis probes will be inserted into a paraspinal muscle Subcutaneous microdialysis catheters: Two dialysis probes will be inserted into a paraspinal subcutaneous region | 0 | 6 | 0 | 6 | 0 | 6 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |