Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial.
Dinna N Cruz, Massimo Antonelli, Roberto Fumagalli...
https://pubmed.ncbi.nlm.nih.gov/19531784Actively Recruiting
Led by Careggi Hospital · Updated on 2025-02-12
1000
Participants Needed
15
Research Sites
N/A
Total Duration
C
Careggi Hospital
Lead Sponsor
U
University of Florence
Collaborating Sponsor
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
Use of EBPT in Critically Ill Patients With AKI and/or Multiorgan Failure
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
G
Gianluca Villa, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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