Using blood purification therapy for critically ill patients

Extracorporeal Blood Purification Therapy in Critically Ill Patients: an Interactive,Web-based,Multicenter,Observational Prospective Registry

This study is trying to see which critically ill patients can benefit the most from a special blood purification treatment to help improve their recovery from serious conditions like kidney injury and sepsis.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Sex: All
• Sponsor: Careggi Hospital (other)
• Locations: 1 site (Florence)
• Trial ID: NCT04580680 on ClinicalTrials.gov

What this trial studies

This observational registry aims to identify subpopulations of critically ill patients who benefit most from extracorporeal blood purification (EBP) therapies, particularly focusing on the oXiris membrane. The study collects data from over 50 centers worldwide, utilizing a web-based platform that facilitates easy data entry and enhances collaboration among clinicians. It includes decision support tools to help personalize treatment at the bedside, thereby integrating clinical practice with research. The goal is to clarify the efficacy of EBP in removing inflammatory mediators and improving outcomes in patients with conditions like acute kidney injury and sepsis.

Who should consider this trial

Good fit: Ideal candidates include critically ill patients admitted to the ICU who require extracorporeal blood purification treatments.

Not a fit: Patients who do not require extracorporeal blood purification or are not critically ill may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify which critically ill patients are most likely to benefit from blood purification therapies, potentially improving their outcomes.

How similar studies have performed: While there have been mixed results in previous studies regarding the efficacy of EBP, this registry approach is novel and aims to clarify its benefits in specific patient populations.

Eligibility criteria

Inclusion Criteria: patients who meet all the following inclusion criteria may be included in this study:

1. Admission to ICU
2. Indications for at least one of the following extracorporeal blood purification treatments:

   1. Continuous Renal Replacement Therapy (CRRT) / Intermittent Hemodialysis (IHD) / Hybrid therapies for renal support/replacement;
   2. Immunomodulation therapy in critically ill patients using hemodiafilters with larger pore sizes characterized by enhanced transmembrane clearance of larger molecules (such as cytokines), hemodiafilters with enhanced unselective absorption of cytokines and/or endotoxins, cartridges with enhanced absorption of cytokines and/or endotoxins, techniques aimed at improving extracorporeal removal of cytokines and/or endotoxins.

It should be underlined that the lack of established guidelines on the use of membranes for extracorporeal blood purification (and on RRTs in general) leads to variability in clinical practice and treatments are initiated in accordance with the judgement of the responsible physician. Under these circumstances, it is preferable to keep inclusion criteria as wide as possible so as to obtain a real picture of clinical practice worldwide.

Exclusion Criteria: besides contraindications to the use of the EBP adopted (as from the manual of instructions), there are no exclusion criteria.

Where this trial is running

Florence

• Azienda Ospedaliero Universitaria Careggi — Florence, Italy (RECRUITING)

Study contacts

• Principal investigator: Gianluca Villa, md — University of Florence, Florence, Italy
• Study coordinator: Gianluca Villa, MD

Conditions: Critical Illness, Acute Kidney Injury, Sepsis, Systemic Inflammatory Response Syndrome