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Trial record 30 of 32 for:    shock | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

Development of a Web-based Multicenter Registry on the Use of oXiris Membrane for Extracorporeal Blood Purification Therapies in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03807414
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : July 25, 2019
University of Florence
Information provided by (Responsible Party):
Gianluca Villa, Careggi Hospital

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.

Condition or disease Intervention/treatment
Critical Illness Acute Kidney Injury Sepsis Systemic Inflammatory Response Syndrome Device: oXiris

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Web-based Multicenter Registry on the Use of oXiris Membrane for Extracorporeal Blood Purification Therapies in Critically Ill Patients
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : June 30, 2022

Group/Cohort Intervention/treatment
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
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.

Primary Outcome Measures :
  1. Identification of the subpopulation of critically ill patients that most benefits from EBPT with oXiris [ Time Frame: 7 days after EBPT initiation ]
    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

Secondary Outcome Measures :
  1. Description of the over-time variation of clinical variables during EBPT with oXiris. [ Time Frame: 24 hours after EBPT initiation ]
    This over-time variation will be expresed, for each variable, as a percentage variation compared with the baseline value (at the EBPT initiation).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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").


Inclusion Criteria:

  • critically ill patients in the ICU
  • treatment with oXiris

Exclusion Criteria:

  • age < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03807414

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Contact: Gianluca Villa, MD +393207615547
Contact: Silvia Benemei, MD +390552751889

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Azienda Ospedaliero Universitaria Careggi Recruiting
Florence, Italy, 50100
Contact: Gianluca Villa, MD    +393207615547   
Principal Investigator: Gianluca Villa, MD         
Sponsors and Collaborators
Careggi Hospital
University of Florence
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Principal Investigator: Gianluca Villa, MD U. of Florence- Dept of Health Sciences


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Responsible Party: Gianluca Villa, Principal investigator, Careggi Hospital Identifier: NCT03807414     History of Changes
Other Study ID Numbers: CEAVC14334
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gianluca Villa, Careggi Hospital:
intensive care unit
Additional relevant MeSH terms:
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Acute Kidney Injury
Critical Illness
Systemic Inflammatory Response Syndrome
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases