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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

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 - Microcirculatory response to cytokine removal therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53033
Enrollment
40
Registered
2018-08-01
Start date
2020-03-01
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microcirculatie en weefseldoorbloeding sepsis and acute kidney injury

Interventions

Data obtained in septic shock patients with AKI treated with CVVHD+ CytoSorb (group 1) will be compared with microcirculatory measurements and biomarkers obtained in septic shock patients with AKI w

Sponsors

Erasmus Universiteit Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime frame
Is cytokine removal with a CytoSorb adsorber during septic shock with AKI able to alter the pathophysiologic changes of the microcirculation?

Secondary

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026