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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drexel University
• Collaborator: The Center for Pediatric Pharmacotherapy
• Treatments: Cefazolin; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

Patients eligible to participate in the study must have a need for continuous renal replacement therapy (CRRT) of any modality:

1. CVVH-continuous veno-venous hemofiltration

2. CVVHD-continuous veno-venous hemodialysis

3. CVVHDF-continuous veno-venous hemodiafiltration

Exclusion Criteria:

Patients will be considered ineligible if they meet any of the following criteria:

1. 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)

2. Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)

3. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data

4. Females that are pregnant or breastfeeding