Evaluating blood purification therapies in critically ill patients
Use of EBPT in Critically Ill Patients With AKI and/or Multiorgan Failure: a Multicenter Prospective Observational Registry
This study is testing if certain blood purification treatments can help critically ill patients with kidney problems or multiple organ failure feel better and recover faster.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Careggi Hospital Academic / other |
| Locations | 15 sites (Empoli, Firenze and 14 other locations) |
| Trial ID | NCT04033224 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to assess the effectiveness of extracorporeal blood purification therapies (EBPT) in critically ill patients suffering from acute kidney injury and/or multiorgan failure. The study will analyze whether specific subpopulations of patients benefit more from these therapies, particularly focusing on their hemodynamic stability and multiorgan dysfunction scores. By identifying these clusters, the research seeks to enhance the personalized application of EBPT in critical care settings.
Who should consider this trial
Good fit: Ideal candidates include critically ill patients in the ICU who require specific EBPT interventions for renal support or immunomodulation.
Not a fit: Patients receiving only Cytosorb® and/or Toraymyxin® therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for critically ill patients, potentially enhancing their recovery and survival rates.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of EBPT, but there is potential for identifying specific patient subpopulations that may benefit, suggesting a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * critically ill patients in the ICU * one of this EPB therapy: * CRRT/IHD/Hybrid therapies for support//replacement renal function * immunomodulation achieved by "high cut-off membranes", "endotoxins and/or cytokines adsorbent membranes" or by high-volume hemofiltration Exclusion Criteria: * patients treated only by Cytosorb® and/or Toraymyxin® therapies
Where this trial is running
Empoli, Firenze and 14 other locations
- Ospedale S. Giuseppe — Empoli, Firenze, Italy (Recruiting)
- Ospedale Versilia — Lido di Camaiore, Lucca, Italy (Recruiting)
- Humanitas Research Hospital — Rozzano, Milano, Italy (Recruiting)
- IRCCS Policlinico S. Donato — San Donato Milanese, Milano, Italy (Recruiting)
- Ospedale S. Gerardo — Monza, Monza-Brianza, Italy (Recruiting)
- Ospedale A. Perrino — Brindisi, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Careggi — Florence, Italy (Recruiting)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
- Ospedale S. Jacopo — Pistoia, Italy (Recruiting)
- Ospedale S. Stefano — Prato, Italy (Recruiting)
- Grande Ospedale Metropolitano "Bianchi Melacrino Morelli" — Reggio Calabria, Italy (Recruiting)
- Policlinico Universitario Fondazione Agostino Gemelli — Roma, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Sant'Andrea — Roma, Italy (Recruiting)
- Ospedale Maria Vittoria — Torino, Italy (Recruiting)
- Ospedale S. Bortolo — Vicenza, Italy (Recruiting)
Study contacts
- Principal investigator: Gianluca Villa, MD — University of Florence, Florence, Italy
- Study coordinator: Gianluca Villa, MD
- Email: gianluca.villa@unifi.it
- Phone: +393207615547
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.