Cefazolin Pharmacokinetics: Elimination Clearance in Neonates
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|ClinicalTrials.gov Identifier: NCT01295606|
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : December 13, 2011
To document cefazolin disposition (concentration/time profile, protein binding, metabolism, renal elimination characteristics) and its covariates in neonates following intravenous administration of the drug at induction of anesthesia, prior to an invasive procedure
To evaluate if optimalisation of cefazolin dose regimen during neonatal life is needed
|Condition or disease||Intervention/treatment||Phase|
|Prophylaxis||Drug: Cefazolin||Phase 4|
Prospective, single-center, open label study on the pharmacokinetics of iv cefazolin administration in neonates admitted in the neonatal intensive care unit, University Hospitals Leuven, Belgium.
Patients will be included after signed informed consent of the parents.
Our aim is to include 40 neonates. Cefazolin has been selected for this study as it is routinely administered in neonates undergoing invasive procedures in our unit. At this stage, we only have the intention to document pharmacokinetics and covariates based on the current clinical practice and therefore will not interfere with either clinical indication, or with dosing as prescribed by the attending physician.
Drug administration and collection of samples will be obtained to the current clinical and nursing standard procedures.
Routine clinical care for scheduled invasive procedures in neonates in our unit is intravenous administration of cefazolin as follows:
- 50 mg/kg, 3 times a day
- an extra dose of 50mg/kg is given after 3 hours for operations longer than 3 h
- each time one dose/day is excluded for neonates with body weight <2000 g and postnatal age (PNA) <7 days,
- for invasive operations (e.g. open-heart surgery, laparotomy) the prophylactic administration of cefazolin may be continued for 3-5 days following the completion of surgery.
The antibiotic agent should be administered 30 minutes to 1 hour prior to the start of surgery so that adequate antibiotic levels. Cefazolin is administered to the neonate, through a peripherally inserted venous catheter, during 30 minutes.
Blood will be collected in heparinised tubes through an indwelling arterial line, or deep venous access, always when other routine blood samples are collected for clinical purposes (pO2, pCO2, pH).
Urine samples will be collected through a bladder catheter in patients in whom a bladder catheter is available for clinical indications.
Pharmacokinetic analysis A population pharmacokinetics approach will be used, hereby comparing the data on PK already reported in adults or older children and the newly collected data during neonatal life.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cefazolin Pharmacokinetics: Elimination Clearance in Neonates|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
No Intervention: Cefazolin, antibiotic prophylaxis
All included patients will received iv cefazolin
iv cefazolin (50mg/kg, 3 times a day) will be given as a routine prophylaxis treatment
Other Name: Kefzol
- Pharmacokinetics of iv cefazolin in neonates [ Time Frame: up to 24 h following the first dose administration (in surgical procedures with forein-body implantation up to 48 h following the first dose administration) ]
- Optimalisation of cefazolin dose regimen during neonatal life [ Time Frame: up to 24 h following the first dose administration (in surgical procedures with forein-body implantation up to 48 h following the first dose administration) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295606
|Principal Investigator:||Karel Allegaert, MD PhD||University Hospitals Leuven|