Cytokine Hemoadsorption in ECMO Patients

May 21, 2021 updated by: Jernej Berden, University Medical Centre Ljubljana
Cytokine hemoadsorption is a novel therapy used to improve outcome in critically ill patients with a dysregulated cytokine response and hemodynamic instability. Patients on extracorporeal membraneous oxygenation (ECMO) often develop severe systemic inflammatory response syndrome (SIRS). Cytokine removal using different types of hemoadsorption devices is believed to block the vicious circle of inflammation dysregulation when other basic therapeutic measures fail. To date there are very limited reports on ECMO and cytokine hemoadsorption combination therapy. The aim of this retrospective study is to evaluate feasibility and effectiveness of hemoadsorption in veno-arterial and veno-venous ECMO patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Center Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients on VA ECMO or VV ECMO treated with hemoadsorption

Description

Inclusion Criteria:

  • VA/VV ECMO
  • hemoadsorption
  • Age ≥ 18 years

Exclusion Criteria:

  • no additional exclusion criteria after being eligible for ECMO

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Veno-arterial ECMO patients
Patients with severe SIRS post extracorporeal cardiopulmonary resuscitation (ECPR) or accompanying cardiogenic shock who were treated with hemoadsorption.
Veno-venous ECMO patients
Patients with refractory septic shock on VV ECMO who were treated with hemoadsorption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemodynamic stabilization
Time Frame: Within 12 hours after hemoadsorption
Decreased need for vasopressors according to vasoactive-inotropic score and increase in mean arterial pressure
Within 12 hours after hemoadsorption

Secondary Outcome Measures

Outcome Measure
Time Frame
Lactate, interleukin-6, C-reactive protein and procalcitonin clearance
Time Frame: Within 12 hours after hemoadsorption
Within 12 hours after hemoadsorption
Weaning from ECMO
Time Frame: from day of ECMO-implant for every 24 hours until date of weaning or death, whichever came first, assessed up to 90 days
from day of ECMO-implant for every 24 hours until date of weaning or death, whichever came first, assessed up to 90 days
ICU length of stay
Time Frame: from day of ICU-admission for every 24 hours until date of discharge or death, whichever came first, assessed up to 90 days
from day of ICU-admission for every 24 hours until date of discharge or death, whichever came first, assessed up to 90 days
Hospital mortality
Time Frame: from day of hospital admission until date of discharge or death, whichever came first, assessed up to 90 days
from day of hospital admission until date of discharge or death, whichever came first, assessed up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Haemoadsorption ECMO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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