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Completed

NCT Number: NCT04567199

Influence of Cytosorb on Amount of Catecholamine and Mortality in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General and Surgical Critical Care Medicine, Medical University of Innsbruck

Innsbruck, 6020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational, retrospective

Other

retrospective analysis of observed results, for both study groups.

Primary outcomes

  1. Catecholamine rate over time

    Time frame: 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

    Change of Catecholamine rate [µg of catecholamine/kilogram of body weight /minute].

Secondary outcomes

  1. Length of stay

    Time frame: Begin of Sepsis until discharge [up to 54 weeks]

    Length of stay in hospital

  2. Overall survival

    Time frame: Begin of Sepsis until discharge [up to 54 weeks]

    Amount of survivors at discharge

  3. 28 day survival

    Time frame: Begin of Sepsis and day 28

    Amount of survivors at timepoint day 28 [in % of all patients]

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2020
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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