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

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.

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03672149
Enrollment
20
Registered
2018-09-14
Start date
2019-07-18
Completion date
2022-12-31
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics, Renal Replacement Therapy

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.

Interventions

DRUGCefazolin

Mixing cefazolin into the CRRT solution(s) for delivery as a continuous infusion

Sponsors

The Center for Pediatric Pharmacotherapy
CollaboratorUNKNOWN
Drexel University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

1. 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 . 2. 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 . 3. 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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cefazolin serum levels72-96 hoursTherapeutic serum cefazolin levels. Serum samples will be obtained at specified intervals during the course of CRRT for cefazolin concentration determination.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026