Influence of Cytosorb on Amount of Catecholamine and Mortality in Sepsis

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567199
• Other study ID #: 1124/2018
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: September 2020
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catecholamine
• Cytokine Release Syndrome
• Cytokine Storm
• Sepsis
• Septic Shock
• Toxemia

Intervention

Other:
• Observational, retrospective
retrospective analysis of observed results, for both study groups.

Locations

Country	Name	City	State
Austria	General and Surgical Critical Care Medicine, Medical University of Innsbruck	Innsbruck

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of stay	Length of stay in hospital	Begin of Sepsis until discharge [up to 54 weeks]
Secondary	Overall survival	Amount of survivors at discharge	Begin of Sepsis until discharge [up to 54 weeks]
Secondary	28 day survival	Amount of survivors at timepoint day 28 [in % of all patients]	Begin of Sepsis and day 28