Extended project description

GlobalARRT is an international, multicenter, prospective observational registry aimed at describing and analyzing Extracorporeal Blood Purification (EBP) therapies in critically ill patients worldwide.

 

The primary objective of this registry-based study is to define the possible clusters of critically ill patients – treated with EBP therapies worldwide – that are homogeneous regarding both clinical and treatment characteristics and who seem to benefit the most from a specific EBP therapy.

Furthermore, data prospectively collected in the GlobalARRT registry will be used for describing::

  • EBP utilization rates in intensive care units worldwide;

  • EBP in terms of treatment type in intensive care units worldwide;

  • EBP in terms of technical characteristics in intensive care units worldwide;

  • The clinical circumstances under which clinicians opt for specific techniques of extracorporeal blood purification therapy worldwide.

  • Identify early changes in clinical parameters that may be associated with a positive long-term outcome during extracorporeal blood purification treatments.

  • Identify early changes in clinical parameters that can be linked to a positive hospital outcome following the prescription of such treatments.

  • Determine late changes in clinical parameters that can be traced to a positive hospital outcome following the prescription of such treatments.

The GlobalARRT registry aims at observing critically ill patients with AKI and multiorgan dysfunction treated with EPB. Patient enrollment will coincide with EBP treatment start date (independently prescribed by the attending physician according to widely accepted guidelines and local clinical practice). Patients will be monitored and data recorded until ICU discharge. Post-discharge follow-up has not been envisaged.

All medical institutions that provide EBP treatments to critically ill patients are eligible for participation.

Patients who meet all the following inclusion criteria may be included in this study:

  1. Admission to ICU

  2. Indications for at least one of the following extracorporeal blood purification treatments:

  • 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.

 

Besides contraindications to the use of the EBP adopted (as from the manual of instructions), there are no exclusion criteria.

The GlobalARRT registry database facilitates collection and management of clinical and multiparametric data of patients undergoing EBP, with the purpose of identifying possible clusters of patients who seem to benefit the most from a specific EBP therapy. Such a multidisciplinary approach might enhance personalized EPB treatments and improve patient outcomes.

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Data will be recorded using the study management software REDCap®. REDCap is a secure web application for building and managing online databases. It has many features, including:

  1. user-friendly interface for entering, editing, and saving validated data;

  2. audit trails for tracking data manipulation and user activity;

  3. automated export procedures for seamless data downloads to Excel, PDF, and common statistical packages;

  4. procedures for importing data from external sources.

The GlobalAART registry platform has been designed to meet the needs of any professionals and facilitate the interaction between clinicians and the data collection software through personalized tools.

 

Furthermore, it adopts a proactive approach, in the sense that it includes several automatic calculators and decision support tools that might help clinicians to personalize treatments directly at the bedside (e.g. automatic calculation of clinical scoring systems, ideal body weight, mechanical ventilation setting, antibiotic adjustment according to renal function, etc.). 

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The GlobalARRT registry provides a clear example of translational medicine and translational research where data from clinical practice feed a database for clinical research and, contemporaneously, the database research tools improve clinical practice.

 

Finally, the registry allows each participating center to instantaneously evaluate its own data and obtain real-time basic statistics for each recorded variable (e.g. age at enrollment, main comorbidities, baseline serum creatinine, mortality rate, rate of multidrug-resistant bacteria, etc.), thus allowing for continuous monitoring of outcomes and local practices.

Analysis of the subpopulation of patients treated with oXiris is of particular interest to the project and is supported by a Baxter Investigator Initiated Research grant awarded to the University of Florence. 

ClinicalTrials.gov identifier (NCT number): NCT03807414

By clicking on the button displayed above you can download the article:

oXirisNet Registry: A Prospective, National Registry on the oXiris Membrane

“Science is made of data like a house is made of stones. But a heap of data is no more science than a pile of stones is a real house. " 

HENRI POINCARÉ