Idiopathic ScoliosisPhase 4NCT03190668
Skeletal Muscle and Adipose Tissue Study
A Phase 4 study testing Bolus dose of Cefazolin, Continuous Cefazolin drip and Paraspinal muscle microdialysis catheters in people with Idiopathic Scoliosis, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Bolus dose of Cefazolin, Continuous Cefazolin drip and Paraspinal muscle microdialysis catheters
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 23 Jun 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skeletal Muscle and Adipose Tissue Concentrations of Cefazolin Comparing Two Different Dosing Regimens During Pediatric Posterior Spinal Fusion Surgery
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.
Read the 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.
- Conditions
- Idiopathic Scoliosis
- Being tested
- Bolus dose of Cefazolin, Continuous Cefazolin drip, Paraspinal muscle microdialysis catheters, Subcutaneous microdialysis catheters
- Keywords
- tissue microdialysis, spinal fusion, surgical site infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bolus dose of CefazolinDrug
Also called Standard mode of prophylactic cefazolin administration
Mode of Cefazolin administration will be a intermittent bolus
Continuous Cefazolin dripDrug
Also called Continuous infusion of prophylactic cefazolin
Mode of Cefazolin administration will be a continuous drip
Paraspinal muscle microdialysis cathetersDevice
Also called Paraspinal muscle dialysate sample
Two dialysis probes will be inserted into a paraspinal muscle
Subcutaneous microdialysis cathetersDevice
Also called Subcutaneous dialysate sample
Two dialysis probes will be inserted into a paraspinal subcutaneous region
| Study group | Role | What they receive |
|---|---|---|
| First Regimen Group | Active comparator | 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. Receives: Drug: Bolus dose of Cefazolin; Device: Paraspinal muscle microdialysis catheters; Device: Subcutaneous microdialysis catheters |
| Second Regimen Group | Active comparator | 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. Receives: Drug: Continuous Cefazolin drip; Device: Paraspinal muscle microdialysis catheters; Device: Subcutaneous microdialysis catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unbound Cefazolin Concentration in Skeletal Muscle
First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle
Measured: Changes from baseline (pre-op) up to end of surgical procedure
Unbound Cefazolin in Adipose Tissue
First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of adipose tissue
Measured: Changes from baseline (pre-op) up to end of surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start29 May 2018
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Seubert, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190668
- Sponsor's protocol ID
- IRB201701129 -A
- Other IDs
- OCR18899
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2017
- Last updated
- 11 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle and Adipose Tissue Concentrations of Cefazolin Comparing Two Different Dosing Regimens During Pediatric Posterior Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT03190668
- Acronym / sponsor ID
- IRB201701129 -A
- Conditions
- Idiopathic Scoliosis
- Keywords
- tissue microdialysis, spinal fusion, surgical site infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Posted 11 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| First Regimen Group | Active comparator | Drug: Bolus dose of Cefazolin, Device: Paraspinal muscle microdialysis catheters, Device: Subcutaneous microdialysis cathetersThe 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 | Active comparator | Drug: Continuous Cefazolin drip, Device: Paraspinal muscle microdialysis catheters, Device: Subcutaneous microdialysis cathetersThe 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. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bolus dose of CefazolinAlso: Standard mode of prophylactic cefazolin administrationMode of Cefazolin administration will be a intermittent bolus | Drug | First Regimen Group |
| Continuous Cefazolin dripAlso: Continuous infusion of prophylactic cefazolinMode of Cefazolin administration will be a continuous drip | Drug | Second Regimen Group |
| Paraspinal muscle microdialysis cathetersAlso: Paraspinal muscle dialysate sampleTwo dialysis probes will be inserted into a paraspinal muscle | Device | First Regimen Group, Second Regimen Group |
| Subcutaneous microdialysis cathetersAlso: Subcutaneous dialysate sampleTwo dialysis probes will be inserted into a paraspinal subcutaneous region | Device | First Regimen Group, Second Regimen Group |
Primary outcome
Unbound Cefazolin Concentration in Skeletal Muscle
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
Unbound Cefazolin in Adipose Tissue
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Seubert, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bolus dose of Cefazolin, Continuous Cefazolin drip and Paraspinal muscle microdialysis catheters in people with Idiopathic Scoliosis, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unbound Cefazolin Concentration in Skeletal Muscle (time frame: Changes from baseline (pre-op) up to end of surgical procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.