Effect of CytoSorb adsorber on hemodynamic and immunological parameters in critical ill patients with COVID-19

Not Applicable

• Conditions: COVID-19 engl.; U07.1; COVID-19, virus identified

• Registration Number: DRKS00021199
• Lead Sponsor: niversitätsklinikum Hamburg Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-07
• Study Completion: 2021-07-01
• Results First Posted: 2022-09-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Confirmed COVID-19
2. refractory shock (mean arterial pressure = 65mmHg due to vasopressor therapy and adequate volume resuscitation; norepinephrine = 0.2µg/kg bodyweight; Interleukine-6 = 500ng/l
3. indication for continuous renal replacement procedure pr extracorporeal membrane oxygenation
4. age = 18 years and = 90 years

Exclusion Criteria

1. Liver Cirrhosis Child-Pugh C
2. therapy restriction (DNR), moribund patient
3. expected survival due to concomitant diseases = 14 days
4. pregnancy or lactation
5. participation in another interventional study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. change in organ function by day 10 or dismissal from ICU, assessment based on SOFA score<br>2. improving lactate clearance by lowering serum lactate Levels<br>3. duration of renal replacement procedure<br>4. Duration of extracorporeal Membrane oxygenation procedure<br>5. reducing the length of stay in intensive care unit<br>6. reducing the length of mechanical Ventilation<br>7. cumulative catecholamine dose<br>8. Overall mortality and mortality in intensive care unit after 28 and 90 days<br>9. Change of plasma Interleukin-6 (IL6) level <br>10. Change of plasma Interleukin-10 (IL10) Level<br>11. Change of plasma Procalcitonin (PCT) level <br>12. Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes<br>13. Change of TNF alpha level after ex-vivo stimulation with LPS