Influence of Cytosorb on Amount of Catecholamine and Mortality in Sepsis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Retrospective Analysis of the Influence of Cytosorb on Catecholamine Reduction and Mortality in SIRS and Sepsis

Conditions
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Sepsis, Septic Shock, Cytokine Storm, Cytokine Release Syndrome, Catecholamine

Intervention / Treatment
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* Other: Observational, retrospective


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cytosorb recipients<br>Patients receiving Cytosorb due to septic shock. SOFA score, Changes in catecholamine support after CytoSorb initiation Survival to discharge ICU Survival >28d Thromboembolic events General data: Need of catecholamines Type of extra-corporal treatments Anticoagulation medication Concomitant allogenic blood products Concomitant factor concentrates Bleeding events Vital signs Underlying Disease SAPSII, SAPSIII, SOFA Scores (on 1st day of treatment) Type of Pathogen (gram+, gram-, fungi) Sepsis Multi Organ Failure Data records: Myoglobin, CK (creatine kinase), CK-MB, Fibrinogen D-dimers, Antithrombin III, Procalcitonin Creatinin, urea, Natrium, Potassium, Bilirubin, GOT (glutamate-oxalacetate transaminase), GPT, GGT (glutamate-pyruvate transaminase), PT (prothrombin time) aPTT (activated partial thromboplastin time) CRP (C reactive protein) Blood count Further parameters if of interest | Other: Observational, retrospective<br>* retrospective analysis of observed results, for both study groups.<br>|
| Non Cytosorb recipients<br>Patients not receiving Cytosorb due to septic shock. Patients not treated with CytoSorb under suspicion for inflammation, septic shock or SIRS will be searched for same characteristics as the first group. These groups will be matched when parameters like epidemiology, infectious parameters, prognostic scores, age, gender amount of catecholamines fit best. Parameters as in Group of Cytosorb recipients | Other: Observational, retrospective<br>* retrospective analysis of observed results, for both study groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catecholamine rate over time | Change of Catecholamine rate [µg of catecholamine/kilogram of body weight /minute]. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Length of stay in hospital | Begin of Sepsis until discharge [up to 54 weeks] | 
| Overall survival | Amount of survivors at discharge | Begin of Sepsis until discharge [up to 54 weeks] | 
| 28 day survival | Amount of survivors at timepoint day 28 [in % of all patients] | Begin of Sepsis and day 28 |