Clinical Trial: Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Validation of Central Venous (Port A Cath®) Blood Draws for Ciprofloxacin Pharmacokinetic Research in Patients Under Treatment for Childhood Cancer

Brief Summary: To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic studies of ciprofloxacin in patients under treatment for childhood cancer.

Detailed Summary: 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.
Sponsor: Universitair Ziekenhuis Brussel

Current Primary Outcome: Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction [ Time Frame: 1 hour ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Universitair Ziekenhuis Brussel

Dates:
Date Received: July 27, 2016
Date Started: March 2016
Date Completion: March 2017
Last Updated: November 15, 2016
Last Verified: June 2016