Development of a Web-based Multicenter Registry on the Use of oXiris Membrane for EBPTs in Critically Ill Patients

NCT03807414 | Active Not Recruiting FDA Device

• 1 other identifier: CEAVC14334
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 12

Brief Summary

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 oXiris membrane.

Conditions

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

Keywords

intensive care unit; regisrty; endotoxin; heparin

Outcome Measures

Primary Outcomes (1)

• Identification of the subpopulation of critically ill patients that most benefits from EBPT with oXiris

  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 regression analyses with the patient's survival at hospital discharge will be identified and expressed with their Odds ratios, 95%CI and p-value

  10 days after EBPT initiation

Secondary Outcomes (1)

• Description of the over-time variation of clinical variables during EBPT with oXiris.

  24 hours after EBPT initiation

Study Arms (1)

Critically ill patients

In centres that obtained IRB approval for this prospective study, all critically ill adult patients (\>18yrs) undergoing treatment with oXiris will be prospectively observed.

Device: oXiris

Interventions

oXiris DEVICE

Every center will prescribe EBPT with oXiris 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.

Critically ill patients

Eligibility Criteria

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

Study Population

All critically ill patients undergoing EBPT with oXiris membrane 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").

You may qualify if:

• critically ill patients in the ICU
• treatment with oXiris

You may not qualify if:

• age \< 18 years

Sponsors & Collaborators

• Careggi Hospital: lead
• University of Florence: collaborator

Study Sites (12)

Presidio Ospedaliero di Esine

Esine, Brescia, 25040, Italy

Location

S. Giuseppe Hospital

Empoli, Firenze, 50053, Italy

Location

IRCCS Policlinico S. Donato Milanese

San Donato Milanese, Milano, 20097, Italy

Location

Ospedale Sacro Cuore di Gesù-Fatebenefratelli

Benevento, 82100, Italy

Location

Azienda Ospedaliero Universitaria Careggi

Florence, 50100, Italy

Location

A.O.U. della Campania "L. Vanvitelli"

Napoli, 80138, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Ospedale S. Maria della Misericordia

Perugia, 06129, Italy

Location

Ospedale San Jacopo

Pistoia, 51100, Italy

Location

S.Camillo Forlanini Hospital

Roma, 00149, Italy

Location

Cristo Re Hospital

Roma, 00167, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

Related Publications (7)

• 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

• Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536.

  PMID: 24401721 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, Fioccola A, Cecchi M, Scire Calabrisotto C, Pomare Montin D, De Rosa S, Scoccia G, Manno A, Tofani L, Santorsola C, Patera F, Capitanini A, Resta MV, Ferrari F, Greco M, Rossi F, Ricci Z, Ronco C, Romagnoli S; OxirisNET registry working group. Use of Oxiris membrane in real-world clinical practice in critical care patients: a multicenter observational study. J Anesth Analg Crit Care. 2025 Dec 15;5(1):91. doi: 10.1186/s44158-025-00305-3.

  PMID: 41398301 DERIVED

• Santorsola C, Corona A, Cecchi M, Nicolini NC, Zendra E, Capone A, Gatti I, Brivio M, Falsini S, Villa G. Dynamic CRRT Prescription for Complicated Critically Ill Patient: A Case Report. Case Rep Crit Care. 2024 Nov 20;2024:1837150. doi: 10.1155/2024/1837150. eCollection 2024.

  PMID: 39611098 DERIVED

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

  U. of Florence- Dept of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 16, 2019
• Study Start: June 28, 2019
• 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 (12)