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

NCT ID: NCT03672149

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-18
• Study Completion Date: 2022-12-31

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.

Conditions

Renal Replacement Therapy; Pharmacokinetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Infection needing cefazolin

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.

Group Type: OTHER

Cefazolin

Intervention Type: DRUG

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

Infection not needing cefazolin

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.

Group Type: OTHER

Cefazolin

Intervention Type: DRUG

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

No infection

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.

Group Type: OTHER

Cefazolin

Intervention Type: DRUG

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

Interventions

Cefazolin

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

Intervention Type: DRUG

Other Intervention Names

CRRT solutions

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Center for Pediatric Pharmacotherapy

UNKNOWN

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey J. Cies,PharmD,MPH,BCPS-AQ ID,BCPPS,FCCP,FCCM,FPPAG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Jeffrey Cies

Role: primary

jeffrey.cies@gmail.com

215-427-5176

Other Identifiers

1805006375

Identifier Type: -

Identifier Source: org_study_id