R57.2
Conditions
Interventions
Group 1: Hemoadsorption and filtration
with the Oxiris® filter for 72 hours in the intervention group
Group 2: Hemoadsorption and filtration with standard hemofilters in the control group
Sponsors
Klinik für Anästhesiologie Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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 6 hrs and refractary pulmonary fluid overload, formation/worsening of a pulmonary edema (defined as bilateral infiltrations with a PaO2/FIO2 10% of admission weight) or 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to resolution of septic shock, defined as a catecholamine dose of norepinephrine <0.2 ug / kg / min | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular factors - Trends of cardiac output and systemic resistance, based on measurements, using the thermodilution method (PiCCO®) - Maximum dose of catecholamines required - Duration of the need for catecholamine therapy Microcirculatory factors - Lactate, value at study inclusion (baseline) and trend - Mottling score, value at study inclusion (baseline) and trend - Hyperspectral imaging Plasma cytokine levels - Interleukin (IL) -1, IL-4, IL-6, IL-8, IL-10, IL-11, IL-13, tumor necrosis factor (TNF) -alpha, transforming growth factor (TGF) -beta and interferon (IFN) -gamma values at study inclusion (baseline) and trends (laboratory measurement) Inflammation parameters - C-reactive protein (CRP) and procalcitonin (PCT), values at study inclusion (baseline) and trends (laboratory examination) Organ dysfunction - Sequential Organ Failure Assessment Score (SOFA), values at study inclusion (baseline) and trends Mortality - 30 days mortality Economic factors -Duration of the need for invasive ventilation -Duration of the need for intensive care therapy Nephrological parameters - Acute kidney failure, maximum value and trends based on the Kidney Disease Improving Global Outcome (KDIGO) classification Clinical Chemistry - E.g., trends of lactate dehydrogenase, aspertate aminotransferase, alanine aminotransferase, bilirubin, INR, partial thromboplastin time, fibrinogen Advanced immunodiagnostics - Measurement of HLA-DR expression on CD14 + monocytes (flow cytometric measurement with CE / IVD certified kit) - Determination of the percentage and absolute number of T, B and natural killer cells (NK cells) as well as the CD4 and CD8 subpopulations of T cells (flow cytometric measurement with CE / IVD certified kit) - Metabolome analysis (MxP®Quant 500 kit, biocrates) | — |
Countries
Germany
Contacts
Public ContactBenjamin Tan
Klinik für Anästhesiologie Universitätsklinikum Heidelberg
Outcome results
None listed