Cytokine Hemoadsorption in ECMO Patients

NCT04901338 | Completed

• 1 other identifier: Haemoadsorption ECMO
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SIRS; Cytokine Storm; Cardiogenic Shock; Cardiac Arrest; Septic Shock; ARDS, Human

Keywords

Hemoadsorption; ECMO; SIRS; ARDS; Post-resuscitation syndrome; ECPR

Outcome Measures

Primary Outcomes (1)

• Haemodynamic stabilization

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

  Within 12 hours after hemoadsorption

Secondary Outcomes (4)

• Lactate, interleukin-6, C-reactive protein and procalcitonin clearance

  Within 12 hours after hemoadsorption

• Weaning from ECMO

  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

  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

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on VA ECMO or VV ECMO treated with hemoadsorption

You may qualify if:

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Cytokine Release Syndrome; Shock, Cardiogenic; Heart Arrest; Shock, Septic; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Sepsis; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jernej Berden, MD, PhD

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 25, 2021
• Study Start: June 1, 2017
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

SL (1)