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Trial record 29 of 32 for:    shock | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

Use of EBPT in Critically Ill Patients With AKI and/or Multiorgan Failure: a Multicenter Prospective Observational Registry

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ClinicalTrials.gov Identifier: NCT04033224
Recruitment Status : Not yet recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
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 different EBPTs.

Condition or disease Intervention/treatment
Critical Illness Acute Kidney Injury Sepsis Systemic Inflammatory Response Syndrome Device: Commercial membrane for Extracorporeal Blood Purification Therapy (EBPT)

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Use of Extracorporeal Blood Purification Therapies in Critically Ill Patients With Acute Renal Injury and / or Multiorgan Failure: a Multicenter Prospective Observational Registry
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Group/Cohort Intervention/treatment
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)
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.




Primary Outcome Measures :
  1. Identification of the subpopulation of critically ill patients that most benefits from EBPTs. [ 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 stepwise 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 EBPs [ Time Frame: 24 hours after EBPT initiation ]
    This over-time variation will be expressed, for each variable, as a percentage variation compared with the baseline value (at the EBPT initiation).



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Ages Eligible for Study:   Child, 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 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").

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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 ClinicalTrials.gov identifier (NCT number): NCT04033224


Contacts
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Contact: Gianluca Villa, MD +393207615547 gianluca.villa@unifi.it

Sponsors and Collaborators
Careggi Hospital
University of Florence

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Responsible Party: Gianluca Villa, Principal investigator, Careggi Hospital
ClinicalTrials.gov Identifier: NCT04033224     History of Changes
Other Study ID Numbers: ARRT_aRIA
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 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
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Shock
Critical Illness
Systemic Inflammatory Response Syndrome
Multiple Organ Failure
Disease Attributes
Pathologic Processes
Urologic Diseases
Inflammation