Back to resultsSkeletal Muscle and Adipose Tissue Study
Primary Purpose
Idiopathic Scoliosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bolus dose of Cefazolin
Continuous Cefazolin drip
Paraspinal muscle microdialysis catheters
Subcutaneous microdialysis catheters
Sponsored by
About this trial
This is an interventional prevention trial for Idiopathic Scoliosis focused on measuring tissue microdialysis, spinal fusion, surgical site infection
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of idiopathic scoliosis
- Planned posterior spinal fusion surgery (PSFS)
- Age: 12-20 years old
- American Society of Anesthesiology status I or II undergoing posterior spinal fusion for at least 6 levels
- No known allergy to cefazolin
Exclusion Criteria:
- Known allergy to cefazolin
- Anatomical or other abnormalities that precluded insertion of a microdialysis catheter into the selected paraspinal muscle
- Known renal or hepatic insufficiency or failure
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
First Regimen Group
Second Regimen Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Unbound Cefazolin Concentration in Skeletal Muscle
First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle
Unbound Cefazolin in Adipose Tissue
First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of adipose tissue
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03190668
Brief Title
Skeletal Muscle and Adipose Tissue Study
Official Title
Skeletal Muscle and Adipose Tissue Concentrations of Cefazolin Comparing Two Different Dosing Regimens During Pediatric Posterior Spinal Fusion Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
June 23, 2022 (Actual)
Study Completion Date
June 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Scoliosis
Keywords
tissue microdialysis, spinal fusion, surgical site infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First Regimen Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Second Regimen Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bolus dose of Cefazolin
Other Intervention Name(s)
Standard mode of prophylactic cefazolin administration
Intervention Description
Mode of Cefazolin administration will be a intermittent bolus
Intervention Type
Drug
Intervention Name(s)
Continuous Cefazolin drip
Other Intervention Name(s)
Continuous infusion of prophylactic cefazolin
Intervention Description
Mode of Cefazolin administration will be a continuous drip
Intervention Type
Device
Intervention Name(s)
Paraspinal muscle microdialysis catheters
Other Intervention Name(s)
Paraspinal muscle dialysate sample
Intervention Description
Two dialysis probes will be inserted into a paraspinal muscle
Intervention Type
Device
Intervention Name(s)
Subcutaneous microdialysis catheters
Other Intervention Name(s)
Subcutaneous dialysate sample
Intervention Description
Two dialysis probes will be inserted into a paraspinal subcutaneous region
Primary Outcome Measure Information:
Title
Unbound Cefazolin Concentration in Skeletal Muscle
Description
First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle
Time Frame
Changes from baseline (pre-op) up to end of surgical procedure
Title
Unbound Cefazolin in Adipose Tissue
Description
First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of adipose tissue
Time Frame
Changes from baseline (pre-op) up to end of surgical procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of idiopathic scoliosis
Planned posterior spinal fusion surgery (PSFS)
Age: 12-20 years old
American Society of Anesthesiology status I or II undergoing posterior spinal fusion for at least 6 levels
No known allergy to cefazolin
Exclusion Criteria:
Known allergy to cefazolin
Anatomical or other abnormalities that precluded insertion of a microdialysis catheter into the selected paraspinal muscle
Known renal or hepatic insufficiency or failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Seubert, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Skeletal Muscle and Adipose Tissue Study
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