In Vivo Antibiotics Removal During Hemoadsorption Cartridges and Continuous Renal Replacement Therapy in the Intensive Care Unit

NCT07230041 | Recruiting DMC

• 1 other identifier: 4747
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure the change in plasma concentrations of antibiotics used during passage through the CRRT filter and hemadsorption cartridge in patients with septic shock and renal failure requiring CRRT. All patients aged \> 18 years, admitted to the ICU, diagnosed with septic shock and renal failure requiring CRRT, receiving antibiotic therapy with at least one of the following drugs: meropenem, linezolid, and daptomycin, who provided informed consent, are included in the study. Patients not admitted to the ICU, patients with renal failure not requiring CRRT, patients aged \< 18 years, or those who did not provide informed consent are excluded. The enrollment period will last 12 months and will run from September 2024 to September 2025. The expected number of patients enrolled is twenty. To proceed with the study, after starting antibiotic therapy, a 4 ml dose of blood will be drawn (Vacuette tube ref. 454092) before the cartridge, immediately after, and after the dialysis filter. This measurement will be repeated after 4, 8, and 12 hours, which represents the maximum usage time of the cartridge. After 12 hours, the cartridge becomes saturated and loses its adsorption capacity. The CRRT filter, however, remains in place for at least 72 hours before being replaced. Treatment is maintained until clinically necessary. For patients in intensive care, several blood samples are required throughout the day, both with a blood sample sent to the biochemistry laboratory every 6-8 hours to check clinical conditions, and with an arterial blood sample (blood gas) to check respiratory and metabolic status in patients on mechanical ventilation. Furthermore, in patients undergoing CRRT, electrolyte balance must be monitored every 4 hours. Therefore, the blood sample for the study inevitably coincides with one of the routine blood samples. The test tube, labeled with a unique code, will be sent to the central laboratory, which will centrifuge the blood and extract the plasma. This aliquot will then be stored at -80°C in a dedicated space and sent to the designated laboratory upon analysis. Determination of the plasma dosage of the antibiotic in use is commonly performed on patients admitted to the Intensive Care Unit, where clinically necessary. Participation in the study does not change current clinical practices.

Conditions

Septic Shock

Keywords

antibiotic; target drug monitoring; meropenem; linezolid; daptomycin; in vivo

Outcome Measures

Primary Outcomes (1)

• drug concentration

  assess the percentage of drug concentration variation pre and post HA 380 cartridge

  4 hours

Secondary Outcomes (1)

• drug concentration variation

  8 and 12 hours

Study Arms (1)

ICU patients with a diagnosis of infection/sepsis/septic shock

* stage 3 KDIGO consensus criteria, indication to CRRT * use of at least one of the following antibiotics meropenem, linezolid and daptomycin

Diagnostic Test: Liquid Chromatography - Tandem Mass Spectrometry

Interventions

Liquid Chromatography - Tandem Mass Spectrometry DIAGNOSTIC_TEST

The samples will be processed by a company with expertise in antibiotic TDM. To ensure the highest standards of accuracy and reliability in our data, blood samples collected during this study will be evaluated using state-of-the-art Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS) techniques. This advanced analytical method allows for the precise quantification and identification of biochemical compounds within complex biological matrices, providing unparalleled sensitivity and specificity. Following collection, blood is centrifuged to separate serum or plasma, which is then aliquoted to avoid degradation from freeze-thaw cycles. Aliquots are stored at -80°C to preserve sample integrity until analysis. This meticulous pre-analytical preparation ensures that all samples can be analyzed simultaneously, reducing analytical variability, and maintaining the quality of the samples for LC-MS/MS analysis

ICU patients with a diagnosis of infection/sepsis/septic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients with a diagnosis of infection/sepsis/septic shock

You may qualify if:

• stage 3 KDIGO consensus criteria, indication to CRRT
• use of at least one of the following antibiotics meropenem, linezolid and daptomycin
• \< 18 yo

You may not qualify if:

• \< 18 yo

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

Niguarda Hospital

Milan, Italia, 20162, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Sara Micol Santambrogio, MD

  Niguarda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Micol Santambrogio, MD

CONTACT

+390264441; saramicol.santambrogio@ospedaleniguarda.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2025
• First Posted: November 17, 2025
• Study Start: January 15, 2025
• Primary Completion: December 15, 2025
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

IT (1)