Skeletal Muscle and Adipose Tissue Study

Idiopathic Scoliosis Clinical Trial

Official title:

Skeletal Muscle and Adipose Tissue Concentrations of Cefazolin Comparing Two Different Dosing Regimens During Pediatric Posterior Spinal Fusion Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190668
• Other study ID #: IRB201701129 -A
• Secondary ID: OCR18899
• Status: Completed
• Phase: Phase 4
• Start date: May 29, 2018
• Est. completion date: June 23, 2022

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 23, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

Drug:
• Bolus dose of Cefazolin
Mode of Cefazolin administration will be a intermittent bolus
• Continuous Cefazolin drip
Mode of Cefazolin administration will be a continuous drip

Device:
• 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

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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