Skeletal Muscle and Adipose Tissue Study

Phase 4

Completed

• Conditions: Idiopathic Scoliosis
• Interventions: Drug: Continuous Cefazolin drip; Drug: Bolus dose of Cefazolin; Device: Paraspinal muscle microdialysis catheters; Device: Subcutaneous microdialysis catheters

• Registration Number: NCT03190668
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Study Start: 2018-05-29
• Primary Completion: 2022-06-23
• Study Completion: 2022-06-23
• Results First Submitted: 2023-05-25
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-22
• Last Update Submitted: 2023-06-22
• Results First Posted: 2023-07-11
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
First Regimen Group	Subcutaneous microdialysis catheters	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.
Second Regimen Group	Continuous Cefazolin drip	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.
Second Regimen Group	Paraspinal muscle microdialysis catheters	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.
First Regimen Group	Bolus dose of Cefazolin	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.
Second Regimen Group	Subcutaneous microdialysis catheters	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.
First Regimen Group	Paraspinal muscle microdialysis catheters	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States