Development of a Web-based Multicenter Registry on the Use of oXiris Membrane for Extracorporeal Blood Purification Therapies in Critically Ill Patients
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|ClinicalTrials.gov Identifier: NCT03807414|
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : July 25, 2019
|Condition or disease||Intervention/treatment|
|Critical Illness Acute Kidney Injury Sepsis Systemic Inflammatory Response Syndrome||Device: oXiris|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||270 participants|
|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|
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.
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.
- 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
- 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).
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 ClinicalTrials.gov identifier (NCT number): NCT03807414
|Contact: Gianluca Villa, MDfirstname.lastname@example.org|
|Contact: Silvia Benemei, MDemail@example.com|
|Azienda Ospedaliero Universitaria Careggi||Recruiting|
|Florence, Italy, 50100|
|Contact: Gianluca Villa, MD +393207615547 firstname.lastname@example.org|
|Principal Investigator: Gianluca Villa, MD|
|Principal Investigator:||Gianluca Villa, MD||U. of Florence- Dept of Health Sciences|