CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Antibiotics +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04033029
NCT04033029N/ACompleted

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

Hospital Universitari de Bellvitge·observational·Posted Jul 25, 2019·Updated Oct 10, 2023

In Brief

An observational study evaluating Continuous venovenous hemodiafiltration with high adsorption membrane (oXiris®) and Antibiotics for Hemodiafiltration and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

* 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 25, 2019
Enrollment StartJan 1, 2021
Primary CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.9 years ago

Interventions

Continuous venovenous hemodiafiltration with high adsorption membrane (oXiris®)device

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).

Antibioticsdrug

Antibiotic concentration-time data will be collected and analyzed.