Clinical trial

Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy With a High Adsorption Membrane (oXiris®)

Name

HCC-PIP-2018-01

Description

* Study: Open label, non-randomized, observational, descriptive and prospective pharmacokinetic. * Patients: sepsis patients undergoing continuous renal replacement therapy (CRRT) and admitted at the Intensive care unit of Bellvitge University Hospitals. No power calculations needed. * Antibiotic treatment: piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin as their standard of care and doses will be at the discretion of the treating physician. * CRRT treatment: continuous venovenous hemodiafiltration (CVVHDF) will be performed by using the PrismafleX eXeed™ system with a high adsorbent membrane (oXiris®). * Antibiotic concentrations: blood pre and post filter, urine and ultrafiltrate samples will be collected at steady state conditions. Samplig time will depend on dosage regimens of each antibiotic.

Trial arms

Trial start

2021-01-01

Estimated PCD

2023-06-30

Trial end

2023-06-30

Status

Completed

Treatment

Continuous venovenous hemodiafiltration with high adsorption membrane (oXiris®)

CRRT initiation will be determined by the treating physician on charge, according with the current recommendations of clinical practice and prescriptions of CRRT and local management protocols. The CVVHDF mode will be performed by using PrismafleX eXeed™ system and high adsorbent polyethyleneimide membrane (oXiris®). Filtration parameters will be determined following the local protocol (dose of 25-30 ml/kg/h).

Arms:

Patients under CVVHDF with high adsorption membrane

Antibiotics

Antibiotic concentration-time data will be collected and analyzed.

Arms:

Patients under CVVHDF with high adsorption membrane

Other names:

Piperacillin/tazobactam, Ceftazidime, Cefepime, Daptomycin, Ceftolozane/tazobactam

Size

Primary endpoint

Number of individuals attaining a defined pharmacokinetic-pharmacodynamic target for antimicrobial therapy

01/08/2019 - 31/12/2021

Eligibility criteria

Inclusion Criteria: * Patients in the setting of sepsis and requirements of CRRT with high adsorption membranes for at least 48 h * Age \>18 years * Treatment with piperacillin, ceftazidime, cefepime, ceftolozane and daptomycin prescribed at the discretion of the treating intensive care physician. * Written informed consent will be required before the inclusion of a patient whenever possible and will be requested from the nearest relatives in the other cases. Exclusion Criteria: none.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood, ultrafiltrate and urine samples.'}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

Updated at

2023-10-10

1 organization

1 product

3 indications

Organization

Hospital Universitari de Bellvitge

Product

Indication

Indication

Indication