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To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic studies of ciprofloxacin in patients under treatment for childhood cancer.
The concentration of cipro will be determined using a validated high-performance liquid chromatographic (HPLC) method with fluorescence detection. Unbound concentration will be determined by adjusting the pH of the plasma samples to physiological pH (7.4) in a CO2 incubator, followed by ultrafiltration and extraction of ciprofloxacin from the ultrafiltrate (as described above) prior to injection onto the HPLC system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofloxacin administration | Other | Blood will be drawn, in all participants, via Port A Cath and via a peripheral draw. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin administration | Other | Ciprofloxacin will be administered via the PAC directly followed by a NaCl 0.9% flush to wash the PAC. At least 1 hour afterwards 500 microliter of blood will be drawn via the PAC. Directly hereafter a blood draw of 500 microliter will be performed either via capillary blood sampling or via a venipuncture. If an anaesthesia is foreseen for another procedure (e.g. a lumbar puncture or an osseous punction), we will strive to perform the peripheral blood draw under anaesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction | 1 hour |
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Inclusion Criteria:
Children who
Exclusion Criteria:
Children will be excluded from this study if we are unable to
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Meesters, MD MPH | Contact | kevin.meesters@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Jutte van der Werff ten Bosch, MD PhD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Brussels | 1090 | Belgium |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| D062666 | Vascular Access Devices |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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|
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D057785 | Catheters |
| D004864 | Equipment and Supplies |