Safety and Therapeutic Drug Monitoring of Cefazolin in Continuous Renal Replacement Therapy
- Registration Number
- NCT03672149
- Lead Sponsor
- Drexel University
- Brief Summary
This investigation is intended to collect safety information for the technique of mixing cefazolin in the CRRT solution on the CRRT circuit, the patient, in addition to collecting information regarding the ability to obtain therapeutic cefazolin serum concentrations
- Detailed Description
This investigation is intended to collect safety information for the technique of mixing cefazolin in the CRRT solution on the CRRT circuit, the patient, in addition to collecting information regarding the ability to obtain therapeutic cefazolin serum concentrations in addition to utilizing a dosing algorithm to adjust the cefazolin concentration in the CRRT solution.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Patients eligible to participate in the study must have a need for continuous renal replacement therapy (CRRT) of any modality:
- CVVH-continuous veno-venous hemofiltration
- CVVHD-continuous veno-venous hemodialysis
- CVVHDF-continuous veno-venous hemodiafiltration
Patients will be considered ineligible if they meet any of the following criteria:
- History of any moderate or severe hypersensitivity or allergic reaction to cefazolin (a history of mild rash followed by uneventful re-exposure and/or red man syndrome is not a contraindication)
- Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
- Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data
- Females that are pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Infection needing cefazolin Cefazolin a) If a patient requires antimicrobial therapy for a proven or suspected infection at the time of CRRT initiation or at any time receiving CRRT, they are eligible for inclusion. If cefazolin is part of the empiric or definitive treatment regimen, it will be mixed in the CRRT solution(s) and administered via a continuous infusion to obtain pharmacokinetic and safety data of administering cefazolin via the CRRT solution and infection treatment related data. For this indication, pharmacokinetic and safety data will be obtained for the duration the patient receives cefazolin via the CRRT solution(s) for the proven or suspected infection as dictated by the primary team caring for the patient. Infection not needing cefazolin Cefazolin b) If a patient is deemed a candidate for CRRT and requires therapy with any anti-microbial for a proven or suspected infection not requiring cefazolin as part of the anti-microbial drug regimen, administration of cefazolin via the CRRT solution(s) will occur to solely obtain pharmacokinetic and safety data. For this indication, pharmacokinetic and safety data will be obtained for a 72-96-hour duration. No infection Cefazolin c) If a patient is deemed a candidate for CRRT and does not require any anti-microbial therapy, administration of cefazolin via the CRRT solution(s) will occur to solely obtain pharmacokinetic and safety data. For this indication, pharmacokinetic and safety data will be obtained for a 72-96-hour duration.
- Primary Outcome Measures
Name Time Method Cefazolin serum levels 72-96 hours Therapeutic serum cefazolin levels. Serum samples will be obtained at specified intervals during the course of CRRT for cefazolin concentration determination.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States