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Skeletal Muscle and Adipose Tissue Study

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ClinicalTrials.gov Identifier: NCT03190668
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Idiopathic Scoliosis Drug: Bolus dose of Cefazolin Drug: Continuous Cefazolin drip Device: Paraspinal muscle microdialysis catheters Device: Subcutaneous microdialysis catheters Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Skeletal Muscle and Adipose Tissue Concentrations of Cefazolin Comparing Two Different Dosing Regimens During Pediatric Posterior Spinal Fusion Surgery
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: Bolus dose of Cefazolin
Mode of Cefazolin administration will be a intermittent bolus
Other Name: Standard mode of prophylactic cefazolin administration

Device: Paraspinal muscle microdialysis catheters
Two dialysis probes will be inserted into a paraspinal muscle
Other Name: Paraspinal muscle dialysate sample

Device: Subcutaneous microdialysis catheters
Two dialysis probes will be inserted into a paraspinal subcutaneous region
Other Name: Subcutaneous dialysate sample

Active Comparator: 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.
Drug: Continuous Cefazolin drip
Mode of Cefazolin administration will be a continuous drip
Other Name: Continuous infusion of prophylactic cefazolin

Device: Paraspinal muscle microdialysis catheters
Two dialysis probes will be inserted into a paraspinal muscle
Other Name: Paraspinal muscle dialysate sample

Device: Subcutaneous microdialysis catheters
Two dialysis probes will be inserted into a paraspinal subcutaneous region
Other Name: Subcutaneous dialysate sample




Primary Outcome Measures :
  1. Skeletal muscle disposition of prophylactic Cefazolin [ Time Frame: 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

  2. Adipose tissue disposition of prophylactic Cefazolin [ Time Frame: 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



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Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190668


Contacts
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Contact: Judith M. Wishin, BSN 352-273-9096 jwishin@anest.ufl.edu
Contact: Anna Woods, RN 352-294-8345 awoods@anest.ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Taranjit Sangari, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03190668     History of Changes
Other Study ID Numbers: IRB201701129
OCR18899 ( Other Identifier: University of Florida )
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by University of Florida:
tissue microdialysis
spinal fusion
surgical site infection

Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Dialysis Solutions
Cefazolin
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents