Recruiting

ICAROHemoadsorption Cartridges for Antibiotics Removal in ICU Patients

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Study Aim

This study aims to observe how effective hemoadsorption cartridges are in removing antibiotics from the body of patients in the intensive care unit by measuring changes in drug concentration.

What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Infections+5

+ Inflammation

+ Pathologic Processes

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2025
See protocol details

Summary

Principal SponsorNiguarda Hospital
Study ContactSara Micol Santambrogio, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 15, 2025

Actual date on which the first participant was enrolled.

This study focuses on understanding how certain antibiotics behave in the body when patients in an Intensive Care Unit (ICU) are treated for severe infections like septic shock. The study specifically looks at the combination of antibiotics such as meropenem with either linezolid or daptomycin. These patients are also receiving a treatment called Continuous Renal Replacement Therapy (CRRT), which helps filter waste from the blood when the kidneys are not working well. The study aims to see how a device called the HA380 cartridge affects the levels of these antibiotics in the blood. This is important because understanding how these treatments interact could help improve the effectiveness and safety of treating severe infections in ICU patients. During the study, participants will undergo CRRT using a special machine that includes the HA380 cartridge to filter out inflammatory substances from their blood. Blood samples will be taken at different times to measure how much of the drug is present before and after it passes through the HA380 filter. The samples are carefully processed and stored to ensure accurate measurement using advanced techniques. This study is observational, meaning it looks at what happens naturally without intervening. The researchers will analyze the percentage change in drug concentration to understand the cartridge's impact. This can help determine whether the HA380 cartridge affects the effectiveness of the antibiotics, providing valuable insights into optimizing care for critically ill patients.

Official TitleIn Vivo Antibiotics Removal During Treatment With Hemoadsorption Cartridges and Continuous Renal Replacement Therapy in the Intensive Care Unit
Principal SponsorNiguarda Hospital
Study ContactSara Micol Santambrogio, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsInflammationPathologic ProcessesShockShock, SepticPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeSepsis

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Niguarda Hospital

Milan, ItalyOpen Niguarda Hospital in Google Maps
Recruiting
One Study Center