Safety and Therapeutic Drug Monitoring of Cefazolin in Continuous Renal Replacement Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Open-Label Study of the Safety and Therapeutic Drug Monitoring of Continuous Infusion Cefazolin Through the Addition of the Cefazolin Into the Continuous Renal Replacement Therapy Solution.

Conditions
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Renal Replacement Therapy, Pharmacokinetics

Intervention / Treatment
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* Drug: Cefazolin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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 treatment, pharmacokinetic, and safety data . If cefazolin is not 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 . If a patient does not require any anti-microbial therapy, cefazolin will be given via the CRRT solution(s) to solely obtain pharmacokinetic and safety data.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Infection needing cefazolin<br>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. | Drug: Cefazolin<br>* Mixing cefazolin into the CRRT solution(s) for delivery as a continuous infusion<br>* Other names: CRRT solutions;|
| Other: Infection not needing cefazolin<br>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. | Drug: Cefazolin<br>* Mixing cefazolin into the CRRT solution(s) for delivery as a continuous infusion<br>* Other names: CRRT solutions;|
| Other: No infection<br>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. | Drug: Cefazolin<br>* Mixing cefazolin into the CRRT solution(s) for delivery as a continuous infusion<br>* Other names: CRRT solutions;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cefazolin serum levels | Therapeutic serum cefazolin levels. Serum samples will be obtained at specified intervals during the course of CRRT for cefazolin concentration determination. | 72-96 hours |