Trial Outcomes & Findings for Skeletal Muscle and Adipose Tissue Study (NCT NCT03190668)
NCT ID: NCT03190668
Last Updated: 2023-07-11
Results Overview
First regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
Changes from baseline (pre-op) up to end of surgical procedure
Results posted on
2023-07-11
Participant Flow
Participant milestones
| Measure |
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.
Bolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus
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
|
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.
Continuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip
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
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
First Regimen Group
n=6 Participants
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.
Bolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus
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
|
Second Regimen Group
n=6 Participants
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.
Continuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip
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
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Age, Continuous
|
15.2 years
n=6 Participants
|
12.8 years
n=6 Participants
|
14 years
n=12 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline (pre-op) up to end of surgical procedureFirst regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of skeletal muscle
Outcome measures
| Measure |
First Regimen Group
n=5 Participants
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.
Bolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus
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
|
Second Regimen Group
n=5 Participants
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.
Continuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip
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
|
|---|---|---|
|
Unbound Cefazolin Concentration in Skeletal Muscle
|
3.22 µg/ml/kg
Interval 1.77 to 7.62
|
5.84 µg/ml/kg
Interval 3.01 to 11.35
|
PRIMARY outcome
Timeframe: Changes from baseline (pre-op) up to end of surgical procedureFirst regimen and second regimen difference between unbound Cefazolin concentrations in the interstitial fluid of adipose tissue
Outcome measures
| Measure |
First Regimen Group
n=5 Participants
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.
Bolus dose of Cefazolin: Mode of Cefazolin administration will be a intermittent bolus
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
|
Second Regimen Group
n=5 Participants
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.
Continuous Cefazolin drip: Mode of Cefazolin administration will be a continuous drip
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
|
|---|---|---|
|
Unbound Cefazolin in Adipose Tissue
|
3.21 µg/ml/kg
Interval 2.33 to 8.24
|
6.13 µg/ml/kg
Interval 3.2 to 11.22
|
Adverse Events
First Regimen Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Second Regimen Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place