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CytoSorb in Patients With Liver Failure

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.
 
ClinicalTrials.gov Identifier: NCT04511507
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Popescu Mihai, Institutul Clinic Fundeni

Brief Summary:
Hemoadsorption has been demonstrated to improve liver functional tests in patients with liver failure. The present study investigates the effects of three consecutive sessions of hemoadsorption, performed in accordance to the local protocol for treating patients with acute liver failure, on liver functional tests, severity scores and 30-days mortality. Paraclinical results and severity scores were obtained before and after the three consecutive sessions.

Condition or disease Intervention/treatment
Liver Dysfunction Procedure: hemoadsorption

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Liver Failure
Actual Study Start Date : February 10, 2016
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Group/Cohort Intervention/treatment
liver failure
patients diagnosed with acute liver failure or acute on chronic liver failure in accordance with national guidelines who require 3 consecutive sessions of hemoadsorption
Procedure: hemoadsorption
three consecutive sessions of hemoadsorption in patients with liver failure




Primary Outcome Measures :
  1. 30 days mortality [ Time Frame: 30 days ]
    30 days mortality



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
- patients with acute liver failure or acute on chronic liver failure who require hemoadsorption in accordance with local guidelines. The decision of hemoadsorption is made by the attending physician prior to study inclusion.
Criteria

Inclusion Criteria:

  • patients with acute liver failure or acute on chronic liver failure who require hemoadsorption in accordance with local guidelines

Exclusion Criteria:

  • unsigned informed consent
  • duration of therapy under 12 hours
  • death before the three consecutive sessions

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): NCT04511507


Contacts
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Contact: Dana Tomescu, Prof danatomescu@gmail.com

Locations
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Romania
Fundeni Clinical Institute Recruiting
Bucharest, Romania, 022328
Contact: Dana Tomescu, Prof         
Sponsors and Collaborators
Institutul Clinic Fundeni
Investigators
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Study Chair: Dana Tomescu, Prof Fundeni Clinical Institute
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Responsible Party: Popescu Mihai, Clinical Professor, Institutul Clinic Fundeni
ClinicalTrials.gov Identifier: NCT04511507    
Other Study ID Numbers: Cyto-ALF
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
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: No
Additional relevant MeSH terms:
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Liver Failure
Liver Diseases
Hepatic Insufficiency
Digestive System Diseases