Microcirculatie en weefseldoorbloeding sepsis and acute kidney injury
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Each patient, weight above 60 kg with septic shock needing vasopressors or lower dosis norepinephrine supplemented with dobutamine, vasopressin (argipressin) /terlipressin/epinephrine must meet all of the following criteria to be enrolled in this study: 1. Has written informed consent from patient or legal representative. 2. Is aged 18 to 85 years, inclusive a weight above 60 kg. 3. Is admitted to the ICU 4. Has diagnosis of septic shock according to the criteria defined by Singer et al in the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) published in JAMA, 2016. • Organ dysfunction acute change in total SOFA score >=2 points consequent to the infection or Quick SOFA (qSOFA,): alteration in mental status, systolic blood pressure =22/min. • Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP >=65 mm Hg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation. 5. Has diagnosis of AKI, defined as the following: AKI Stage 2 according to the following KDIGO guidelines criteria, based on changes in Serum Creatinine (SCr), urine output or both: a. Increase in SCr 2.0-2.9 times baseline and or a Urine Output (UO) = 12 hours compared with a SCr value within the previous 48 hours. b. The reference SCr value is a SCr value in the following order of preference: 1. Lowest value within 3 months of hospital admission if not available: 2. At hospital admission. If not available: 3. At ICU admission. If not available: 4. Lowest value between 3 and 12 months prior to hospital admission 6. Has a deteriorated sublingual microcirculation measured by Cytocam-IDF imaging and quantified by determining the MFI as
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: 1. Moribund 2. Woman of childbearing potential with a positive pregnancy test 3. Has a diagnosis of septic shock longer than 24 hours before inclusion 4. Has a normal sublingual microcirculation 5. Neutropenia; absolute neutrophil count less than 1000/um 6. Thrombocytopenia (less than 20.000/um) 7. Any body weight lower than 60 kg. 8. Treatment with intravenous aminoglycosids or antifungal therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Is cytokine removal with a CytoSorb adsorber during septic shock with AKI able to alter the pathophysiologic changes of the microcirculation? | — |
Secondary
| Measure | Time frame |
|---|---|
| • To determine the systemic attenuation of cytokine concentrations in patients with septic shock and AKI initiated on CVVHD in combination with the CytoSorb membrane • To investigate possible adsorption of Neutrophil Gelatinase-associated Lipocalin by the CytoSorb membrane • Determining the effect on ICU outcome, length of stay and SOFA score. | — |
Countries
Netherlands