Extracorporeal Blood Purification Therapy in Critically Ill Patients (GlobalARRT)

NCT04580680 | Recruiting FDA Device

• 1 other identifier: GlobalARRT
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Acute Kidney Injury; Sepsis; Systemic Inflammatory Response Syndrome

Outcome Measures

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).

  10 days after Extracorporeal Blood Purification Therapy (EBPT) initiation

Secondary Outcomes (10)

• To assess the correlation between cluster membership and positive short-term outcome.

  48 hours after EBPT initiation

• To assess the correlation between cluster membership and positive long-term outcome.

  10 days after EBPT initiation

• To assess the correlation between positive short-term outcome and changes from baseline.

  24 hours after EBPT initiation

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

  10 days after EBPT initiation

• To describe the clinical circumstances under which clinicians opt for specific techniques of extracorporeal blood purification therapy worldwide in terms of absolute and relative frequencies of clinical variables.

  10 days after EBPT initiation

Interventions

Commercial membrane for Extracorporeal Blood Purification Therapy (EBPT) DEVICE

At 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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Admission to ICU
• 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.

Sponsors & Collaborators

• Careggi Hospital: lead
• University of Florence: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria Careggi

Florence, 50100, Italy

RECRUITING

Related Publications (6)

• Cruz DN, Antonelli M, Fumagalli R, Foltran F, Brienza N, Donati A, Malcangi V, Petrini F, Volta G, Bobbio Pallavicini FM, Rottoli F, Giunta F, Ronco C. Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA. 2009 Jun 17;301(23):2445-52. doi: 10.1001/jama.2009.856.

  PMID: 19531784 BACKGROUND

• Klein DJ, Foster D, Schorr CA, Kazempour K, Walker PM, Dellinger RP. The EUPHRATES trial (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock): study protocol for a randomized controlled trial. Trials. 2014 Jun 11;15:218. doi: 10.1186/1745-6215-15-218.

  PMID: 24916483 BACKGROUND

• Payen DM, Guilhot J, Launey Y, Lukaszewicz AC, Kaaki M, Veber B, Pottecher J, Joannes-Boyau O, Martin-Lefevre L, Jabaudon M, Mimoz O, Coudroy R, Ferrandiere M, Kipnis E, Vela C, Chevallier S, Mallat J, Robert R; ABDOMIX Group. Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial. Intensive Care Med. 2015 Jun;41(6):975-84. doi: 10.1007/s00134-015-3751-z. Epub 2015 Apr 11.

  PMID: 25862039 BACKGROUND

• Cutuli SL, Artigas A, Fumagalli R, Monti G, Ranieri VM, Ronco C, Antonelli M; EUPHAS 2 Collaborative Group. Polymyxin-B hemoperfusion in septic patients: analysis of a multicenter registry. Ann Intensive Care. 2016 Dec;6(1):77. doi: 10.1186/s13613-016-0178-9. Epub 2016 Aug 8.

  PMID: 27502196 BACKGROUND

• Friesecke S, Trager K, Schittek GA, Molnar Z, Bach F, Kogelmann K, Bogdanski R, Weyland A, Nierhaus A, Nestler F, Olboeter D, Tomescu D, Jacob D, Haake H, Grigoryev E, Nitsch M, Baumann A, Quintel M, Schott M, Kielstein JT, Meier-Hellmann A, Born F, Schumacher U, Singer M, Kellum J, Brunkhorst FM. International registry on the use of the CytoSorb(R) adsorber in ICU patients : Study protocol and preliminary results. Med Klin Intensivmed Notfmed. 2019 Nov;114(8):699-707. doi: 10.1007/s00063-017-0342-5. Epub 2017 Sep 4.

  PMID: 28871441 BACKGROUND

• Villa G, De Rosa S, Samoni S, Neri M, Cosimo C, Romagnoli S, Gavagni M, Ronco C, De Gaudio AR. oXirisNet Registry: A Prospective, National Registry on the oXiris Membrane. Blood Purif. 2019 Apr 11;47 Suppl 3:1-8. doi: 10.1159/000499356. Online ahead of print.

  PMID: 30974438 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Acute Kidney Injury; Sepsis; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Inflammation; Shock

Study Officials

• Gianluca Villa, md

  University of Florence, Florence, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluca Villa, MD

CONTACT

+393207615547; gianluca.villa@unifi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: October 8, 2020
• Study Start: November 1, 2020
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)