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 |
Total
n=35 Participants
Total of all reporting groups
|
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.
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=206 Participants
|
66 years
n=99 Participants
|
62 years
n=107 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=206 Participants
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=206 Participants
|
14 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
|
Body weight
|
68 kilogram
n=206 Participants
|
71 kilogram
n=99 Participants
|
68 kilogram
n=107 Participants
|
|
Acute Physiology and Chronic Health Evaluation (Apache) score
|
25.3 units of the Apache Scoring system
STANDARD_DEVIATION 8.3 • n=206 Participants
|
23.5 units of the Apache Scoring system
STANDARD_DEVIATION 10 • n=99 Participants
|
26.8 units of the Apache Scoring system
STANDARD_DEVIATION 6.9 • n=107 Participants
|
|
Albumin plasma concentration
|
26.7 gram/liter
n=206 Participants
|
23.7 gram/liter
n=99 Participants
|
31.1 gram/liter
n=107 Participants
|
|
alfa-1-acid glycoprotein plasma concentration
|
1.5 gram/liter
n=206 Participants
|
1.4 gram/liter
n=99 Participants
|
1.8 gram/liter
n=107 Participants
|
|
Total plasma protein concentration
|
54.2 gram/liter
STANDARD_DEVIATION 11.5 • n=206 Participants
|
53.4 gram/liter
STANDARD_DEVIATION 12.4 • n=99 Participants
|
56.6 gram/liter
STANDARD_DEVIATION 7.3 • n=107 Participants
|
|
Total plasma bilirubin concentration
|
0.67 milligram/liter
n=206 Participants
|
0.75 milligram/liter
n=99 Participants
|
0.41 milligram/liter
n=107 Participants
|
|
Blood Urea Nitrogen
|
57.5 milligram/deciliter
n=206 Participants
|
54.5 milligram/deciliter
n=99 Participants
|
70 milligram/deciliter
n=107 Participants
|
|
Creatinin plasma concentration
|
1.13 milligram/deciliter
n=206 Participants
|
1.14 milligram/deciliter
n=99 Participants
|
0.95 milligram/deciliter
n=107 Participants
|
|
estimated Glomerular Filtration Rate (CKD-EPI equation)
|
74 ml/min * 1.73m²
n=206 Participants
|
66 ml/min * 1.73m²
n=99 Participants
|
84 ml/min * 1.73m²
n=107 Participants
|
|
C reactive protein plasma concentration
|
71.5 milligram/liter
n=206 Participants
|
72.1 milligram/liter
n=99 Participants
|
47.2 milligram/liter
n=107 Participants
|
|
Voriconazole daily dose
|
NA milligram/kilogram/day
n=206 Participants
|
NA milligram/kilogram/day
n=99 Participants
|
8 milligram/kilogram/day
n=107 Participants
|
|
Total voriconazole plasma concentration
|
2.9 milligram/liter
n=206 Participants
|
NA milligram/liter
n=99 Participants
|
2.4 milligram/liter
n=107 Participants
|
|
Unbound voriconazole plasma concentration
|
0.85 milligram/liter
n=206 Participants
|
0.86 milligram/liter
n=99 Participants
|
0.71 milligram/liter
n=107 Participants
|
|
Bound voriconazole plasma concentration
|
1.62 milligram / liter
n=206 Participants
|
1.63 milligram / liter
n=99 Participants
|
1.52 milligram / liter
n=107 Participants
|
|
Number of coadministered drugs bound to proteins for more then 70%
|
3 number of coadministered drugs
n=206 Participants
|
4.5 number of coadministered drugs
n=99 Participants
|
2.5 number of coadministered drugs
n=107 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