Clinical trial NCT03672149: Safety and Therapeutic Drug Monitoring of Cefazolin in Continuous Renal Replacement Therapy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Renal Replacement Therapy
Pharmacokinetics
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: The Center for Pediatric Pharmacotherapy
First posted: 2018-09-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Cefazolin serum levels
timeFrame: 72-96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
Study officials:
References: