Antibiotic removal during hemoadsorption and continuous kidney support in the ICU
In Vivo Antibiotics Removal During Treatment With Hemoadsorption Cartridges and Continuous Renal Replacement Therapy in the Intensive Care Unit
This project will test how much meropenem, linezolid, or daptomycin is removed from the blood of adults with septic shock and kidney failure who are on CRRT with a hemoadsorption cartridge.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 1 site (Milan, Italia) |
| Trial ID | NCT07230041 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll about 20 adult ICU patients with septic shock and renal failure requiring continuous renal replacement therapy (CRRT) who are receiving meropenem, linezolid, or daptomycin. A single Jafron HA380 hemoadsorption cartridge will be placed in series with a BBraun OMNI PLUS open CVVHD filter for 2–12 hours while standard citrate anticoagulation is used. Blood samples will be drawn before the cartridge, immediately after the cartridge, and after treatment and analyzed by liquid chromatography–tandem mass spectrometry to measure antibiotic concentrations. The goal is to quantify how much of each antibiotic is removed during passage through the hemoadsorption cartridge and CRRT circuit over a 12-month enrollment window.
Who should consider this trial
Good fit: Adults (over 18) admitted to the ICU with septic shock and renal failure requiring CRRT who are receiving meropenem, linezolid, or daptomycin and who provide informed consent.
Not a fit: Patients who are not on CRRT, are under 18, or are not receiving the specified antibiotics are unlikely to benefit from the findings.
Why it matters
Potential benefit: Results could help clinicians adjust antibiotic dosing during hemoadsorption and CRRT to avoid under-dosing and improve infection control.
How similar studies have performed: Previous reports have shown variable antibiotic removal with hemoadsorption and CRRT, but data specific to the HA380 cartridge used with the BBraun OMNI system are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * stage 3 KDIGO consensus criteria, indication to CRRT * use of at least one of the following antibiotics meropenem, linezolid and daptomycin * \< 18 yo Exclusion Criteria: * \< 18 yo
Where this trial is running
Milan, Italia
- Niguarda Hospital — Milan, Italia, Italy (Recruiting)
Study contacts
- Principal investigator: Sara Micol Santambrogio, MD — Niguarda Hospital
- Study coordinator: Sara Micol Santambrogio, MD
- Email: saramicol.santambrogio@ospedaleniguarda.it
- Phone: +390264441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.