Trial Outcomes & Findings for Plasma Protein Binding Characteristics of Voriconazole (NCT NCT01812473)
NCT ID: NCT01812473
Last Updated: 2015-03-24
Results Overview
At steady state plasma concentrations of voriconazole, a plasma sample is taken to determine the overall protein binding of voriconazole. Equilibrium dialysis is used, followed by liquid chromatography-mass spectrometry.
Recruitment status
COMPLETED
Target enrollment
35 participants
Primary outcome timeframe
At steady state plasma concentration of voriconazole (after day 4 of therapy)
Results posted on
2015-03-24
Participant Flow
Participant milestones
| Measure |
Patients Admitted to the ICU Not Treated With Voriconazole
Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.
Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics.
|
Patients Admitted to the ICU Treated With Voriconazole
Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
13
|
|
Overall Study
COMPLETED
|
22
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Plasma Protein Binding Characteristics of Voriconazole
Baseline characteristics by cohort
| Measure |
Patients Admitted Tot the ICU Not Treated With Voriconazole
n=22 Participants
Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.
Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics.
|
Patients Admitted to the ICU Treated With Voriconazole
n=13 Participants
Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
62 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Body weight
|
71 kilogram
n=5 Participants
|
68 kilogram
n=7 Participants
|
68 kilogram
n=5 Participants
|
|
Acute Physiology and Chronic Health Evaluation (Apache) score
|
23.5 units of the Apache Scoring system
STANDARD_DEVIATION 10 • n=5 Participants
|
26.8 units of the Apache Scoring system
STANDARD_DEVIATION 6.9 • n=7 Participants
|
25.3 units of the Apache Scoring system
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Albumin plasma concentration
|
23.7 gram/liter
n=5 Participants
|
31.1 gram/liter
n=7 Participants
|
26.7 gram/liter
n=5 Participants
|
|
alfa-1-acid glycoprotein plasma concentration
|
1.4 gram/liter
n=5 Participants
|
1.8 gram/liter
n=7 Participants
|
1.5 gram/liter
n=5 Participants
|
|
Total plasma protein concentration
|
53.4 gram/liter
STANDARD_DEVIATION 12.4 • n=5 Participants
|
56.6 gram/liter
STANDARD_DEVIATION 7.3 • n=7 Participants
|
54.2 gram/liter
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Total plasma bilirubin concentration
|
0.75 milligram/liter
n=5 Participants
|
0.41 milligram/liter
n=7 Participants
|
0.67 milligram/liter
n=5 Participants
|
|
Blood Urea Nitrogen
|
54.5 milligram/deciliter
n=5 Participants
|
70 milligram/deciliter
n=7 Participants
|
57.5 milligram/deciliter
n=5 Participants
|
|
Creatinin plasma concentration
|
1.14 milligram/deciliter
n=5 Participants
|
0.95 milligram/deciliter
n=7 Participants
|
1.13 milligram/deciliter
n=5 Participants
|
|
estimated Glomerular Filtration Rate (CKD-EPI equation)
|
66 ml/min * 1.73m²
n=5 Participants
|
84 ml/min * 1.73m²
n=7 Participants
|
74 ml/min * 1.73m²
n=5 Participants
|
|
C reactive protein plasma concentration
|
72.1 milligram/liter
n=5 Participants
|
47.2 milligram/liter
n=7 Participants
|
71.5 milligram/liter
n=5 Participants
|
|
Voriconazole daily dose
|
NA milligram/kilogram/day
n=5 Participants
|
8 milligram/kilogram/day
n=7 Participants
|
NA milligram/kilogram/day
n=5 Participants
|
|
Total voriconazole plasma concentration
|
NA milligram/liter
n=5 Participants
|
2.4 milligram/liter
n=7 Participants
|
2.9 milligram/liter
n=5 Participants
|
|
Unbound voriconazole plasma concentration
|
0.86 milligram/liter
n=5 Participants
|
0.71 milligram/liter
n=7 Participants
|
0.85 milligram/liter
n=5 Participants
|
|
Bound voriconazole plasma concentration
|
1.63 milligram / liter
n=5 Participants
|
1.52 milligram / liter
n=7 Participants
|
1.62 milligram / liter
n=5 Participants
|
|
Number of coadministered drugs bound to proteins for more then 70%
|
4.5 number of coadministered drugs
n=5 Participants
|
2.5 number of coadministered drugs
n=7 Participants
|
3 number of coadministered drugs
n=5 Participants
|
PRIMARY outcome
Timeframe: At steady state plasma concentration of voriconazole (after day 4 of therapy)At steady state plasma concentrations of voriconazole, a plasma sample is taken to determine the overall protein binding of voriconazole. Equilibrium dialysis is used, followed by liquid chromatography-mass spectrometry.
Outcome measures
| Measure |
Patients Admitted Tot the ICU Not Treated With Voriconazole
n=66 Plasma samples
Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.
Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics.
|
Patients Admitted to the ICU Treated With Voriconazole
n=20 Plasma samples
Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
|
|---|---|---|
|
Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations.
|
49.1 % of plasma protein binding
Interval 42.6 to 52.3
|
49.6 % of plasma protein binding
Interval 42.5 to 52.5
|
Adverse Events
Patients Admitted Tot the ICU Not Treated With Voriconazole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Admitted to the ICU Treated With Voriconazole
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
Kim Vanstraelen, PharmD
Universitaire Ziekenhuizen Leuven
Phone: 0032 16 342339
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place