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

Pharmacokinetics Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03672149
• Other study ID #: 1805006375
• Status: Recruiting
• Phase: Phase 1
• Start date: July 18, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2020
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics
• Renal Replacement Therapy

Intervention

Drug:
• Cefazolin
Mixing cefazolin into the CRRT solution(s) for delivery as a continuous infusion

Locations

Country	Name	City	State
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	The Center for Pediatric Pharmacotherapy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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