Cytokine Hemoadsorption in ECMO Patients

Completed

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

• Registration Number: NCT04901338
• Lead Sponsor: University Medical Centre Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-05
• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-21
• Last Update Submitted: 2021-05-21
• Study First Posted: 2021-05-25
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

• no additional exclusion criteria after being eligible for ECMO

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Haemodynamic stabilization	Within 12 hours after hemoadsorption	Decreased need for vasopressors according to vasoactive-inotropic score and increase in mean arterial pressure

Secondary Outcome Measures

Name	Time	Method
Lactate, interleukin-6, C-reactive protein and procalcitonin clearance	Within 12 hours after hemoadsorption
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
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
Hospital mortality	from day of hospital admission until date of discharge or death, whichever came first, assessed up to 90 days

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia