Adjuvant Therapy With CytoSorb in Refractory Septic Shock (ACYSS)

Universitätsklinikum Hamburg-Eppendorf

Status: Enrolling

Conditions: Septic Shock

Treatments: Device: CytoSorb-Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04013269

ACYSS

DRKS00015483 (Registry Identifier)

Details and patient eligibility

About

This prospective randomized single center study investigates to what extent the removal of elevated cytokine levels by hemoadsorption has a positive effect on the treatment of patients in septic shock by stabilizing the circulatory situation.

Full description

The term "sepsis" refers to a clinical syndrome in which a dysregulation of the host's inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. Sepsis and septic shock are major causes of death in intensive care units worldwide.

The clinical picture of septic shock, the most severe form of sepsis, leads to uncontrolled production and release of a large number of proinflammatory cytokines and mediators, the "cytokine storm". Septic shock is accompanied by a massive increase in mortality of up to 60%.

This high mortality rate is due to a lack of current treatment options. The early recognition of the disease and its immediate treatment are decisive for successful therapy and the survival of those affected. The most important therapeutic steps, apart from focus control by antibiotics and surgical intervention, are the stabilization of the affected organ systems, in particular the circulatory system and the respiratory system. As an extracorporeal and non-specific procedure for the interruption of the cytokine storm, hemoadsorption by means of CytoSorb adsorbers may be an intervention, which has already demonstrated its basic effectiveness in the treatment of septic and cardiosurgical patients.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Refractory septic shock
• Need for Norepinephrine ≥ 0.25 µg/kg/min
• IL6 ≥ 1000 ng/l
• Indication for CRRT

Exclusion criteria

• Sepsis due to pulmonary or urogenital causes
• Onset of septic shock longer than 36 hours
• Liver cirrhosis Child Pugh C
• "do not resuscitate"-order
• expected survival < 14 days
• participation in another interventional trial
• Pregnancy or breastfeeding
• Lack of consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

CytoSorb-Therapy

Active Comparator group

Description:

Therapy of septic shock using guideline directed standard of care, including continuous renal replacement therapy in combination with haemadsorption using CytoSorb-Adsorber

Treatment:

Device: CytoSorb-Therapy

Standard of care

No Intervention group

Description:

Therapy of septic shock using guideline directed standard of care, including continuous renal replacement therapy