Effect of CytoSorb adsorber on hemodynamic and immunological parameters in refractory septic shock

Not Applicable

Recruiting

Conditions: A41
Other sepsis

Registration Number: DRKS00015483

Lead Sponsor: niversitätsklinikum Hamburg Eppendorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 32

Inclusion Criteria

1. refractory septic shock
2. Guideline directed sepsis therapy (ESICM/SCCM)
3. indication for continuous renal replacement procedure
4. age = 18 years and = 80 years

Exclusion Criteria

1. sepsis due to pneumogenic cause or urosepsis
2. duration of septic shock > 36 hours
3. Liver Cirrhosis Child-Pugh C
4. therapy restriction (DNR), moribund patient
5. expected survival due to concomitant diseases = 14 days
6. pregnancy or lactation
7. 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 vasopressor dose reduction of at least 25% compared to baseline for at least 6 hours within the first 48 hours of treatment.

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. change of innate immune response (reduction of plasma levels of IL-6 and IL-10 (= 20%), PCT, HLA-DR (monocytes), ex vivo TNF response after LPS stimulation)<br>4. duration of renal replacement procedure<br>5. percentage of patients with a reduction in vasopressor dose of at least 25 % compared to baseline for at least 6 hours within the first 24 hours of treatment<br>6. time until septic shock resolution<br>7. reducing the length of stay in intensive care unit<br>8. reducing the length of mechanical ventilation<br>9. cumulative catecholamine dose<br>10. mortality in intensive care unit and overall after 28 and 90 days<br>11. pharmacokinetics of anti-infectives administered under CytoSorb therapy with continuous renal replacement therapy