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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03190668
Other study ID # IRB201701129 -A
Secondary ID OCR18899
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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