Actively Recruiting

All Genders
ID04033224

Use of EBPT in Critically Ill Patients With AKI and/or Multiorgan Failure: a Multicenter Prospective Observational Registry

Led by Careggi Hospital · Updated on 2025-02-12

1000

Participants Needed

15

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Careggi Hospital

Lead Sponsor

U

University of Florence

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the use of extracorporeal blood purification therapies (EBPT) in critically ill patients, especially those with acute kidney injury and multiorgan failure. EBPT is commonly used in critical care to remove inflammatory substances from the blood, aiming to improve organ function. However, previous clinical trials have not consistently shown benefits on long-term outcomes like 28-day or hospital mortality. This study aims to identify specific groups of patients who might benefit most from different EBPT membranes by collecting detailed clinical data. This observational study involves critically ill patients receiving various EBPT treatments for kidney support or immune system modulation, using commercial membranes as prescribed by their healthcare providers. Treatments include continuous renal replacement therapy, intermittent hemodialysis, hybrid therapies, and immunomodulation through special membranes that adsorb endotoxins or cytokines. Each center records detailed treatment settings and patient information via a web-based registry accessible on smartphones and tablets, which also provides helpful clinical tools for managing patient care. Participants will be observed throughout their EBPT treatment, with researchers gathering data on clinical and biochemical changes over time, including scoring systems and other patient characteristics. The main outcome is to identify which patient subpopulations benefit most from EBPT, measured 10 days after treatment starts. The registry allows centers to monitor their own results in real time and supports personalized treatment approaches. The study is ongoing and aims to improve understanding of how to tailor EBPT to individual patient needs while enhancing clinical practice through shared data.

CONDITIONS

Brief Title

Use of EBPT in Critically Ill Patients With AKI and/or Multiorgan Failure

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Critically ill patients in the ICU
  • Receiving EBPT for support or replacement of renal function such as CRRT, IHD, or hybrid therapies
  • Receiving immunomodulation using high cut-off membranes, endotoxin and/or cytokine adsorbent membranes, or high-volume hemofiltration
Not Eligible

You will not qualify if you...

  • Patients treated only with Cytosorb4 and/or Toraymyxin4 therapies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Variable depending on individual treatment duration

Participants who undergo routine extracorporeal blood purification therapy (EBPT) with commercial membranes are observed as part of routine clinical care without changes to their treatment.

Visits as per routine clinical care during EBPT

Long-term Monitoring

Duration - Up to 10 days after EBPT initiation

Participants are observed and their clinical data are recorded over time to identify subpopulations that benefit from EBPT and to monitor clinical variables during and after therapy.

Data collection integrated with routine care visits

Trial Site Locations

Total: 15 locations

1

Ospedale S. Giuseppe

Empoli, Firenze, Italy, 50053

Actively Recruiting

2

Ospedale Versilia

Lido di Camaiore, Lucca, Italy, 55049

Actively Recruiting

3

Humanitas Research Hospital

Rozzano, Milano, Italy, 20089

Actively Recruiting

4

IRCCS Policlinico S. Donato

San Donato Milanese, Milano, Italy, 20097

Actively Recruiting

5

Ospedale S. Gerardo

Monza, Monza-Brianza, Italy, 20900

Actively Recruiting

6

Ospedale A. Perrino

Brindisi, Italy, 72100

Actively Recruiting

7

Azienda Ospedaliero Universitaria Careggi

Florence, Italy, 50100

Actively Recruiting

8

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Actively Recruiting

9

Ospedale S. Jacopo

Pistoia, Italy, 51100

Actively Recruiting

10

Ospedale S. Stefano

Prato, Italy, 59100

Actively Recruiting

11

Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"

Reggio Calabria, Italy, 89124

Actively Recruiting

12

Policlinico Universitario Fondazione Agostino Gemelli

Roma, Italy, 00168

Actively Recruiting

13

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, Italy, 00189

Actively Recruiting

14

Ospedale Maria Vittoria

Torino, Italy, 10144

Actively Recruiting

15

Ospedale S. Bortolo

Vicenza, Italy, 36100

Actively Recruiting

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Research Team

G

Gianluca Villa, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

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David J Klein, Debra Foster, Christa A Schorr...

https://pubmed.ncbi.nlm.nih.gov/24916483

Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial.

Didier M Payen, Joelle Guilhot, Yoann Launey...

https://pubmed.ncbi.nlm.nih.gov/25862039