DRKS00027287Completed未知
Hemadsorption through supportive establishment of an Oxiris® filter in septic shock with suspected cytokine release syndrome - a randomized controlled intervention study - HEMOXISE- HEMoadsorption with OXIris in Septic shock with cytocinE storm- a randomized controlled trial
Klinik für Anästhesiologie Universitätsklinikum Heidelberg0 sites19 target enrollmentStarted: January 24, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 19
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •Written declaration of consent by the study participant or his legally appointed representative
- •- Age = 18 years
- •- Suspected infection
- •- Furthermore, the criteria of septic shock according to the sepsis 3 definition must be met:
- •- Suspected infection (see above)
- •- SOFA score = 2
- •- Vasopressor requirement to maintain adequate hemodynamics (MAP = 65 mmHg), despite sufficient fluid resuscitation
- •- Serum lactate > 2 mmol / l
- •- In addition, there must be suspicion of a cytokine release syndrome, determined with a Point of Care IL-6 test (Milena® Quick Line IL-6 test). Defined as:
- •IL -6 > 300 pg / ml
- •- Furthermore, indications for a renal replacement therapy (RRT) must be met, according to the following absolute or relative criteria:
- •Absolute criteria: Critical ill patient and one of the following:
- •- Blood urea nitrogen > 200 mg/dl
- •- Potassium > 5.8 mmol/l
- •- urine excretion < 0.3 ml/kg/h > 6 hrs and refractary pulmonary fluid overload, formation/worsening of a pulmonary edema (defined as bilateral infiltrations with a PaO2/FIO2 < 300 mmHg and/or positive fluid balance > 10% of admission weight)
- •relative criteria: critical ill patient with acute kidney injury KDIGO 2 or 3 and fullfillment of all three of the following:
- •1. septic shock
- •2. age 18-90 years
- •3. full critical care support planned for at least 3 days
Exclusion Criteria
- •- Not meeting inclusion criteria
- •- Patient refusal
- •- Technically imposssible to conduct renal replacement therapy
- •- Preexisting congestive heart failure, defined as New York Heart Association Klassifikation = II and/or a preexisting left ventricular ejection fraction of < 40%
- •- Heparin allergy or contraindications against heparin use
- •- Suspicion of or confirmed heparin induced thrombocytopenia
- •- Pregnancy
- •- Inclusion in another interventional study
- •- Iatrogenic immunsuppression
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