Extracorporeal Blood Purification Therapy in Critically Ill Patients (GlobalARRT)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCareggi Hospital
About this trial
Worldwide, the use of Extracorporeal Blood Purification (EBP) in everyday clinical practice is becoming increasingly common, particularly in critical care settings. The efficacy of most of these treatments on removal of inflammatory mediators is the main rationale behind the use of EBP in critically ill patients with multiorgan dysfunction. Nonetheless, there are still some doubts as to the clinical efficacy of bacterial toxins and cytokines removal and many clinical trials aiming at exploring the effect of EBP on long-term outcomes of septic patients have failed to demonstrate consistent results regarding 28 day- or hospital-mortality rates. The primary aim of this observational prospective web-based registry is to define the possible clusters of critically ill patients - treated with extracorporeal blood purification therapies worldwide - who are homogeneous regarding both clinical and treatment characteristics and seem to benefit the most from EBP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admission to ICU
Continuous Renal Replacement Therapy (CRRT) / Intermittent Hemodialysis (IHD) / Hybrid therapies for renal support/replacement;
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.
Disqualifiers
None
Trial population
All medical institutions that provide EBP treatments to critically ill patients are eligible for participation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Commercial membrane for Extracorporeal Blood Purification Therapy (EBPT)
DeviceAt each participating center, EBP treatments with commercial membranes will be delivered in accordance with local practice and local levels of expertise. Enrolled patients will not receive additional treatments other than those routinely administered in ICUs. Nonetheless, all parameters settings for EBP treatments will be recorded in the web-based registry and analyzed a posteriori to reveal potential correlations with patient outcomes.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Define the possible clusters of critically ill patients
Define the possible clusters of critically ill patients - treated with extracorporeal blood purification therapies worldwide - that are homogeneous regarding both clinical and treatment characteristics thanks all the treatment and baseline clinical variables extracted from the patient Case Report Forms (CRFs).
Time frame
10 days after Extracorporeal Blood Purification Therapy (EBPT) initiationSecondary outcomes
1
To assess the correlation between cluster membership and positive short-term outcome.
Define as ≥ 20% decrease in Vasoactive-Inotropic Score (VIS) at 48 hours with respect to baseline to assess the correlation between cluster membership and positive short-term outcome (i.e. an improvement in hemodynamic stability and inflammatory status).
Time frame
48 hours after EBPT initiation2
To assess the correlation between cluster membership and positive long-term outcome.
To assess the correlation between cluster membership and positive long-term outcome, defined as patient survival at ICU discharge.
Time frame
10 days after EBPT initiation3
To assess the correlation between positive short-term outcome and changes from baseline.
To assess the correlation between positive short-term outcome and changes from baseline in clinical parameters and all treatment at 12 and 24 hours (as from the patient CRFs).
Time frame
24 hours after EBPT initiation4
To describe the clinical circumstances under which clinicians opt for specific techniques of extracorporeal blood purification therapy worldwide.
Timing of initiation of a specific Extracorporeal Blood Purification (EBT) treatment will be described.
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