Use of EBPT in Critically Ill Patients With AKI and/or Multiorgan Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCareggi Hospital
About this trial
The use of extracorporeal blood purification therapies (EBPT) is becoming increasingly widespread worldwide in everyday clinical practice, particularly in the critical care setting. Nonetheless, most of the clinical trials aimed at exploring the effect of EBPT on patients' long-term outcomes have failed to demonstrate consistent results regarding 28 day- or hospital- mortality rates. The aim of this observational prospective registry is to evaluate if there is a cluster of critically ill patients that mostly benefits from extracorporeal blood purification therapies with different EBPTs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
critically ill patients in the ICU
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
Disqualifiers
patients treated only by Cytosorb® and/or Toraymyxin® therapies
Trial population
All critically ill patients undergoing EBPT in the enrolling centers will be prospectively observed. Although acute kidney injury will be mostly present among the enrolled population, it will be not strictly required as an inclusion criterion. Similarly, although sepsis will be frequently observed, the systemic inflammatory state leading to multiorgan dysfunction and supported by these extracorporeal treatments might have several different etiologies, such as ischemia-reperfusion, severe acute pancreatitis, intoxication, etc. (i.e. "sepsis-like syndromes").
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Commercial membrane for Extracorporeal Blood Purification Therapy (EBPT)
DeviceEvery center will prescribe EBPT with commercial membranes in accordance with local practice and local levels of expertise. No variation in treatment prescription and/or treatment solutions will derive from participation in this prospective observational study. Nonetheless, every setting parameter will be recorded in the web-based registry and analyzed a-posteriori to reveal a potential correlation with the patient outcomes.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Critically ill patients1 intervention
Trial outcomes
Primary outcomes
1
Identification of the subpopulation of critically ill patients that most benefits from EBPTs.
This subpopulation will be described using the baseline variables associated with a positive long-term patient's outcome. In particular baseline variables statistically associated through multivariable stepwise analyses with the patient's survival at hospital discharge will be identified and expressed with their Odds ratios, 95%CI and p-value
Time frame
10 days after EBPT initiationSecondary outcomes
1
Description of the over-time variation of clinical variables during EBPs
This over-time variation will be expressed, for each variable, as a percentage variation compared with the baseline value (at the EBPT initiation).
Time frame
10 days after EBPT initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Careggi Hospital
Lead sponsor
University of Florence
Collaborator
Source ClinicalTrials.gov