CytoSorb in Patients With Liver Failure

• Sponsor: Institutul Clinic Fundeni (Other)
• Overall Status: Completed
• CT.gov ID: NCT04511507
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Actual Duration (Months): 66.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	Phase
Liver Dysfunction	Procedure: hemoadsorption

Study Design

• Study Type: Observational
• Actual Enrollment: 35 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: Feb 10, 2016
• Actual Primary Completion Date: Aug 30, 2021
• Actual Study Completion Date: Aug 30, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 30 days mortality [30 days]

   30 days mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundeni Clinical Institute	Bucharest		Romania	022328

Sponsors and Collaborators

• Institutul Clinic Fundeni

Investigators

• Study Chair: Dana Tomescu, Prof, Fundeni Clinical Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Popescu Mihai, Clinical Professor, Institutul Clinic Fundeni
• ClinicalTrials.gov Identifier: NCT04511507
• Other Study ID Numbers: Cyto-ALF
• First Posted: Aug 13, 2020
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Failure; Liver Diseases

Study Results

No Results Posted as of Sep 5, 2021