Skip to main content
Clinical Trials/NCT04344080
NCT04344080CompletedNot Applicable

Effect of CytoSorb Adsorber on Hemodynamic and Immunological Parameters in Critical Ill Patients With COVID-19

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country24 target enrollmentStarted: April 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours

Study Overview

Brief Summary

This prospective randomized single Center study investigates to what extent the physical elimination of the inflammatory mediators using the CytoSorb adsorber reduces the morbidity of severely and critically ill patients with Covid-19.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • confirmed COVID-19 disease
  • refractory shock with need for norepinephrine ≥ 0.2 μg/kg/min for MAP ≥ 65 mmHg
  • IL6 ≥ 500 ng/l
  • Indication for CRRT or ECMO

Exclusion Criteria

  • Liver cirrhosis Child Pugh C
  • "do not resuscitate"-order
  • expected survival due to comorbidities < 14 days
  • pregnancy or breastfeeding
  • participation in another interventional trial

Outcomes

Primary Outcomes

Percentage of patients with a significant stabilization of hemodynamics for at least 24 hours

Time Frame: 24 hours

Percentage of patients with a significant stabilization of hemodynamics ("shock reversal"), defined as a significant reduction of the noradrenaline dose (≤ 0.05 µg/kg/min) while maintaining mean arterial pressure ≥ 65 mmHg for at least 24 hours compared to control group

Secondary Outcomes

  • Overall and ICU mortality(90 days)
  • Time on mechanical ventilation(10 days)
  • Change of plasma Procalcitonin (PCT) level(10 days)
  • Change of TNF alpha level after ex-vivo stimulation(10 days)
  • Lactate clearance(10 days)
  • Extracorporeal Membrane Oxygenation(10 days)
  • Cumulative catecholamine dose(10 days)
  • Change in organ dysfunction(10 days)
  • Renal replacement therapy(10 days)
  • ICU length of stay(90 days)
  • Change of plasma Interleukin-10 (IL10) level(10 days)
  • Change of plasma Interleukin-6 (IL6) level(10 days)
  • Change of HLA-DR level(10 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials