Trial Outcomes & Findings for Regional Prophylactic Vancomycin in Revision Total Knee Replacement (NCT NCT02020031)
NCT ID: NCT02020031
Last Updated: 2016-11-25
Results Overview
During the procedure, subcutaneous fat samples (approximately 0.5 cm\^3) were taken at regular intervals until skin closure. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
22 participants
Primary outcome timeframe
Baseline to 24 hours
Results posted on
2016-11-25
Participant Flow
Subjects were enrolled between January 2014 and April 2015 at Mayo Clinic in Arizona.
Participant milestones
| Measure |
Vancomycin 500mg Intraosseous
Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
|
Vancomycin 1g IV
Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Vancomycin 500mg Intraosseous
Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
|
Vancomycin 1g IV
Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
Regional Prophylactic Vancomycin in Revision Total Knee Replacement
Baseline characteristics by cohort
| Measure |
Vancomycin 500mg Intraosseous
n=10 Participants
Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
|
Vancomycin 1g IV
n=10 Participants
Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.3 years
n=5 Participants
|
67.4 years
n=7 Participants
|
68.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 hoursDuring the procedure, subcutaneous fat samples (approximately 0.5 cm\^3) were taken at regular intervals until skin closure. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.
Outcome measures
| Measure |
Vancomycin 500mg Intraosseous
n=10 Participants
Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
|
Vancomycin 1g IV
n=10 Participants
Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
|
|---|---|---|
|
Mean Concentration of Vancomycin in Subcutaneous Fat
At approximately 3 minutes
|
94.1 µg/g
Standard Deviation 69.0
|
3.2 µg/g
Standard Deviation 1.8
|
|
Mean Concentration of Vancomycin in Subcutaneous Fat
At approximately 30 minutes
|
88.3 µg/g
Standard Deviation 131
|
5.0 µg/g
Standard Deviation 2.9
|
|
Mean Concentration of Vancomycin in Subcutaneous Fat
At approximately 50 minutes
|
69.4 µg/g
Standard Deviation 50
|
4.2 µg/g
Standard Deviation 2.5
|
|
Mean Concentration of Vancomycin in Subcutaneous Fat
At approximately 115 minutes
|
173 µg/g
Standard Deviation 445
|
4.7 µg/g
Standard Deviation 2.6
|
|
Mean Concentration of Vancomycin in Subcutaneous Fat
At approximately 150 minutes
|
249 µg/g
Standard Deviation 639
|
4.0 µg/g
Standard Deviation 2.2
|
|
Mean Concentration of Vancomycin in Subcutaneous Fat
At approximately 180 minutes
|
18.2 µg/g
Standard Deviation 11.6
|
3.6 µg/g
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: baseline to 24 hoursDuring the procedure, bone samples (approximately 0.5 cm\^3) were taken at regular intervals were taken at regular intervals until skin closure. All bone samples were taken from the femur, distant from the tibial intraosseous injection site. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.
Outcome measures
| Measure |
Vancomycin 500mg Intraosseous
n=10 Participants
Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
|
Vancomycin 1g IV
n=10 Participants
Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
|
|---|---|---|
|
Mean Concentration of Vancomycin in Bone Samples
At approximately 30 minutes
|
90.7 µg/g
Standard Deviation 77
|
7.9 µg/g
Standard Deviation 5.7
|
|
Mean Concentration of Vancomycin in Bone Samples
At approximately 50 minutes
|
193 µg/g
Standard Deviation 191
|
8.6 µg/g
Standard Deviation 5.9
|
|
Mean Concentration of Vancomycin in Bone Samples
At approximately 115 minutes
|
59.8 µg/g
Standard Deviation 63
|
5.0 µg/g
Standard Deviation 2.3
|
|
Mean Concentration of Vancomycin in Bone Samples
At approximately 145 minutes
|
62.9 µg/g
Standard Deviation 62
|
7.1 µg/g
Standard Deviation 4.4
|
Adverse Events
Vancomycin 500mg Intraosseous
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Vancomycin 1g IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vancomycin 500mg Intraosseous
n=10 participants at risk
Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
|
Vancomycin 1g IV
n=10 participants at risk
Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
|
|---|---|---|
|
Renal and urinary disorders
Acute renal failure with olgiurea
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Acute blood loss anemia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Surgical and medical procedures
Intraoperative opiate overdose
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Postoperative hypoxemia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Nervous system disorders
Foot drop of left leg
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Nervous system disorders
Left peroneal neuropathy
|
10.0%
1/10 • Number of events 2
|
0.00%
0/10
|
Other adverse events
| Measure |
Vancomycin 500mg Intraosseous
n=10 participants at risk
Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
|
Vancomycin 1g IV
n=10 participants at risk
Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
|
|---|---|---|
|
Psychiatric disorders
Altered mental state
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Hypotension
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Cardiac disorders
Intermittent atrial tachycardia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Hyponatremia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Surgical and medical procedures
Procedure turned into a brief operation and not full revision
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary bronchitis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Hypovolemic hyponatremia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Acute urinary retention
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Premature ventricular complexes
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Elevated temperature post surgery
|
20.0%
2/10 • Number of events 2
|
0.00%
0/10
|
|
General disorders
Swelling below eyes
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Surgical and medical procedures
Replacement of thoracic pulse generator
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place