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OpenTrials
Completed

NCT Number: NCT04901338

Cytokine Hemoadsorption in ECMO Patients

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.

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Key information

Conditions

SIRS ARDS, Human Cardiac Arrest Cardiogenic Shock Cardiovascular Diseases Cytokine Release Syndrome Cytokine Storm Heart Arrest Heart Diseases Infarction Infections Inflammation Ischemia Lung Diseases Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Sepsis Septic Shock Shock Shock, Cardiogenic Shock, Septic Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no additional exclusion criteria after being eligible for ECMO

Treatment and study plan

Primary outcomes

  1. Haemodynamic stabilization

    Time frame: Within 12 hours after hemoadsorption

    Decreased need for vasopressors according to vasoactive-inotropic score and increase in mean arterial pressure

Secondary outcomes

  1. Lactate, interleukin-6, C-reactive protein and procalcitonin clearance

    Time frame: Within 12 hours after hemoadsorption

  2. 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

  3. 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

  4. Hospital mortality

    Time frame: from day of hospital admission until date of discharge or death, whichever came first, assessed up to 90 days

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 25, 2021
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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