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
Study Sites (1)
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