Cytokine Hemoadsorption in ECMO Patients

Septic Shock Clinical Trial

Official title:

Cytokine Hemoadsorption in ECMO Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901338
• Other study ID #: Haemoadsorption ECMO
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: May 2021
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• VA/VV ECMO

• hemoadsorption

• Age = 18 years

Exclusion Criteria:

• no additional exclusion criteria after being eligible for ECMO

Related Conditions & MeSH terms

• ARDS, Human
• Cardiac Arrest
• Cardiogenic Shock
• Cytokine Storm
• Respiratory Distress Syndrome, Adult
• Septic Shock
• Shock
• Shock, Cardiogenic
• SIRS

Locations

Country	Name	City	State
Slovenia	University Medical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemodynamic stabilization	Decreased need for vasopressors according to vasoactive-inotropic score and increase in mean arterial pressure	Within 12 hours after hemoadsorption
Secondary	Lactate, interleukin-6, C-reactive protein and procalcitonin clearance		Within 12 hours after hemoadsorption
Secondary	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
Secondary	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
Secondary	Hospital mortality		from day of hospital admission until date of discharge or death, whichever came first, assessed up to 90 days