Study into the effect of CytoSorb (cytokine adsorber) in relation to the MICrocirculation of patients with Septic Shock and Acute Kidney Injury at the ICU; MICSS-AKI

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

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 <=100 mm Hg, or respiratory rate >=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) < 0.5
ml-kg-h for >= 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 < 2,6.

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