Use of EBPT in Critically Ill Patients With AKI and/or Multiorgan Failure

NCT04033224 | Recruiting FDA Device

• 1 other identifier: ARRT_aRIA
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 15

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 different EBPTs.

Conditions

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

Outcome Measures

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

  10 days after EBPT initiation

Secondary Outcomes (1)

• Description of the over-time variation of clinical variables during EBPs

  10 days after EBPT initiation

Study Arms (1)

Critically ill patients

In centres that obtained IRB approval for this prospective study, all critically ill patients undergoing EBPTs for support/replacement renal function or immunomodulation will be prospectively observed.

Device: Commercial membrane for Extracorporeal Blood Purification Therapy (EBPT)

Interventions

Commercial membrane for Extracorporeal Blood Purification Therapy (EBPT) DEVICE

Every 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.

Critically ill patients

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 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").

You may qualify if:

• critically ill patients in the ICU
• one of this EPB therapy:
• 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

You may not qualify if:

• patients treated only by Cytosorb® and/or Toraymyxin® therapies

Sponsors & Collaborators

• Careggi Hospital: lead
• University of Florence: collaborator

Study Sites (15)

Ospedale S. Giuseppe

Empoli, Firenze, 50053, Italy

RECRUITING

Ospedale Versilia

Lido di Camaiore, Lucca, 55049, Italy

RECRUITING

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

IRCCS Policlinico S. Donato

San Donato Milanese, Milano, 20097, Italy

RECRUITING

Ospedale S. Gerardo

Monza, Monza-Brianza, 20900, Italy

RECRUITING

Ospedale A. Perrino

Brindisi, 72100, Italy

RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, 50100, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Ospedale S. Jacopo

Pistoia, 51100, Italy

RECRUITING

Ospedale S. Stefano

Prato, 59100, Italy

RECRUITING

Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"

Reggio Calabria, 89124, Italy

RECRUITING

Policlinico Universitario Fondazione Agostino Gemelli

Roma, 00168, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, 00189, Italy

RECRUITING

Ospedale Maria Vittoria

Torino, 10144, Italy

RECRUITING

Ospedale S. Bortolo

Vicenza, 36100, Italy

RECRUITING

Related Publications (5)

• 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

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: July 23, 2019
• First Posted: July 26, 2019
• Study Start: July 16, 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 (15)