Idiopathic Scoliosis
Conditions
Keywords
tissue microdialysis, spinal fusion, surgical site infection
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.
Interventions
DRUGBolus dose of Cefazolin
Mode of Cefazolin administration will be a intermittent bolus
DRUGContinuous Cefazolin drip
Mode of Cefazolin administration will be a continuous drip
DEVICEParaspinal muscle microdialysis catheters
Two dialysis probes will be inserted into a paraspinal muscle
DEVICESubcutaneous microdialysis catheters
Two dialysis probes will be inserted into a paraspinal subcutaneous region
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unbound Cefazolin Concentration in Skeletal Muscle | Changes from baseline (pre-op) up to end of surgical procedure | First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle |
| Unbound Cefazolin in Adipose Tissue | Changes from baseline (pre-op) up to end of surgical procedure | First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of adipose tissue |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| 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 | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Second Regimen Group | Total | First Regimen Group |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 12 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.8 years | 14 years | 15.2 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Unbound Cefazolin Concentration in Skeletal Muscle
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| First Regimen Group | Unbound Cefazolin Concentration in Skeletal Muscle | 3.22 µg/ml/kg |
| Second Regimen Group | Unbound Cefazolin Concentration in Skeletal Muscle | 5.84 µg/ml/kg |
Primary
Unbound Cefazolin in Adipose Tissue
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| First Regimen Group | Unbound Cefazolin in Adipose Tissue | 3.21 µg/ml/kg |
| Second Regimen Group | Unbound Cefazolin in Adipose Tissue | 6.13 µg/ml/kg |