Clinical trial NCT04567199: Influence of Cytosorb on Amount of Catecholamine and Mortality in Sepsis
Official title: Retrospective Analysis of the Influence of Cytosorb on Catecholamine Reduction and Mortality in SIRS and Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Septic Shock
Cytokine Storm
Cytokine Release Syndrome
Catecholamine
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Due to this relatively new treatment concept there is less data at the moment available. 50 patients treated with CytoSorb, if available, in suspicion of severe septic shock will be examined to collect data on outcome. These patients will be compared to 50 patients not treated with CytoSorb. Overall about 100 patients will be analysed.

Brief summary: The aim of this retrospective study was to identify if the enrolled patient might have had a profit of Cytosorb therapy. Primarily the decline in catecholamine therapy under Cytosorb therapy will be investigated. Secondarily the outcome of surviving patients will be evaluated and compared to expected mortality due to sequential organ failure assessment (SOFA). Thirdly the patients deceased under this therapy were compared to the surviving patients.

Detailed description: Severe septic Shock has a high mortality ranging from 30-55% and might lead up to 100% mortality under cardiovascular failure and vasoplegia in the initial phase of severe septic shock . Mostly caused by bacteremia, it can also be triggered by viral or fungal infections. Due to vasodilatation caused by toxins the circulatory system of the patient fails. This will lead to further malfunctions of the patient organs (e.g. renal malfunction, vasodilation, myocardial pump failure and DIG) and will cause multiorgan system failure.

Nowadays there is a symptomatic approach to treat septic shock. Except of giving antibiotics less can be done to improve the patient's condition. Treatment with fluids, catecholamines, mechanical ventilation, renal replacement therapies are all regimen to bridge failed organ systems until normal organ function is restored and starts to improve. It is known that the cytokines and toxins, which are liberated by the breakdown of bacterial cells, maintain the inflammatory response of the body. This process might be overshooting and if not disrupted, the patient will die.

A new approach is to bind this cytokines and toxins in an unspecific physical process to tiny plastic beads, which are arranged in the CytoSorb System as they correlate with severity of mortality in sepsis . This polymer beads allow adsorption and binding of molecules from 5-60 kDa (kilodalton) range. Therefore, Cytokines as IL(interleukin)-1, -6, -8 and -10 can be effectively removed. CytoSorb has to get in contact with patient blood. To use this option of treatment CytoSorb is implemented in a renal replacement system, a heart lung machine, ECMO (extracorporeal membrane oxygenator) or any other extracorporeal pump driven system. By extracorporeal blood purification in septic shock the main goal is to eliminate inflammatory mediators and bacterial toxins. This might attenuate the excessive inflammatory response and could lead to hemodynamic stabilization .

The aim of this retrospective study was to identify if the enrolled patient might have had a profit of Cytosorb therapy. Primarily the decline in catecholamine therapy under Cytosorb therapy will be investigated. Secondarily the outcome of surviving patients will be evaluated and compared to expected mortality due to sequential organ failure assessment (SOFA). Thirdly the patients deceased under this therapy were compared to the surviving patients.

Eligibility criteria: Inclusion Criteria:

* No CytoSorb therapy in patient suspected for sepsis or SIRS (systemic inflammatory response syndrome)
* CytoSorb therapy in patient suspected for sepsis or SIRS

Exclusion Criteria:

* no signs of inflammation
* no sepsis
* no SIRS

Primary outcomes:
measure: Catecholamine rate over time
timeFrame: Begin of Sepsis or Cytosorb [=time 0]; multiple time points (0, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 hours post timepoint 0
Secondary outcomes:
measure: Length of stay
timeFrame: Begin of Sepsis until discharge [up to 54 weeks]
measure: Overall survival
timeFrame: Begin of Sepsis until discharge [up to 54 weeks]
measure: 28 day survival
timeFrame: Begin of Sepsis and day 28
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: General and Surgical Critical Care Medicine, Medical University of Innsbruck
Study officials:
affiliation: Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin
name: Mathias Ströhle, MD
role: PRINCIPAL_INVESTIGATOR
References: