Influence of Cytosorb on Amount of Catecholamine and Mortality in Sepsis

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock; Cytokine Storm; Cytokine Release Syndrome; Catecholamine
• Intervention / Treatment: Other: Observational, retrospective

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.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • General and Surgical Critical Care Medicine, Medical University of Innsbruck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cytosorb recipients; 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; retrospective analysis of observed results, for both study groups.
Non Cytosorb recipients; 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; retrospective analysis of observed results, for both study groups.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Mathias Ströhle, MD, Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): December 1, 2020

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (ACTUAL): September 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Toxemia; Cytokine Release Syndrome
• Other Study ID Numbers: 1124/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymized data regarding the patients condition (lab values, catecholamine need, and other parameters)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No