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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000559-42 | EudraCT Number |
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The purpose of this study is to investigate the influence of hypoalbuminemia on the protein binding characteristics of the antifungal drug voriconazole in ICU patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients admitted to the Intensive Care Unit | All patients admitted to the Intensive Care Unit, treated with voriconazole are eligible for the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other | During the treatment of voriconazole, at steady plasma concentrations of voriconazole, one plasma sample and one serum sample are taken. |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations. | 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. | At steady state plasma concentration of voriconazole (after day 4 of therapy) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the intensive care unit
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| Name | Affiliation | Role |
|---|---|---|
| Kim Vanstraelen, PharmD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Admitted Tot 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations. | 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. | Posted | Median | Inter-Quartile Range | % of plasma protein binding | At steady state plasma concentration of voriconazole (after day 4 of therapy) | Plasma samples | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Admitted Tot 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. |
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Relatively small data set.
Only adult ICU patients.
No data are available for plasma albumin concentrations above 40 g/liter.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Vanstraelen, PharmD | Universitaire Ziekenhuizen Leuven | 0032 16 342339 | kim_vanstraelen@hotmail.com |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Plasma and serum samples are obtained to determine the albumin and alpha-1-acid-glycoprotein level.
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body weight | Median | Inter-Quartile Range | kilogram |
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| Acute Physiology and Chronic Health Evaluation (Apache) score | Calculated as the sum of all parameters described below. Every parameter is scored a value of 0 to +4, 0 being normal +4 being very high or low abnormal. The total apache score ranges from 0 to 71, with higher values being associated with more severe disease and higher mortality risk. Parameters included:Pa02 (arterial blood oxygen tension), rectal body temperature, Mean arterial pressure, arterial pH, heart rate, respiratory rate, serum sodium, serum potassium, serum creatinine, hematocrit, white blood cell count, glasgow coma scale. | Mean | Standard Deviation | units of the Apache Scoring system |
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| Albumin plasma concentration | Median | Full Range | gram/liter |
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| alfa-1-acid glycoprotein plasma concentration | Median | Full Range | gram/liter |
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| Total plasma protein concentration | Mean | Standard Deviation | gram/liter |
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| Total plasma bilirubin concentration | Median | Inter-Quartile Range | milligram/liter |
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| Blood Urea Nitrogen | Median | Inter-Quartile Range | milligram/deciliter |
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| Creatinin plasma concentration | Median | Inter-Quartile Range | milligram/deciliter |
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| estimated Glomerular Filtration Rate (CKD-EPI equation) | Median | Inter-Quartile Range | ml/min * 1.73m² |
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| C reactive protein plasma concentration | Median | Inter-Quartile Range | milligram/liter |
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| Voriconazole daily dose | Median | Inter-Quartile Range | milligram/kilogram/day |
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| Total voriconazole plasma concentration | Median | Inter-Quartile Range | milligram/liter |
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| Unbound voriconazole plasma concentration | Median | Inter-Quartile Range | milligram/liter |
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| Bound voriconazole plasma concentration | Median | Inter-Quartile Range | milligram / liter |
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| Number of coadministered drugs bound to proteins for more then 70% | Mean | Inter-Quartile Range | number of coadministered drugs |
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| OG001 | 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. |
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| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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. | 0 | 13 | 0 | 13 |
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| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |