Influence of Cytosorb on Amount of Catecholamine and Mortality in Sepsis

NCT ID: NCT04567199

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-12-01

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.

Conditions

Sepsis; Septic Shock; Cytokine Storm; Cytokine Release Syndrome; Catecholamine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Observational, retrospective

Intervention Type: OTHER

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

Observational, retrospective

Intervention Type: OTHER

retrospective analysis of observed results, for both study groups.

Interventions

Observational, retrospective

retrospective analysis of observed results, for both study groups.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathias Ströhle, MD

Role: PRINCIPAL_INVESTIGATOR

Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin

Locations

General and Surgical Critical Care Medicine, Medical University of Innsbruck

Innsbruck, , Austria

Countries

Austria

Other Identifiers

1124/2018

Identifier Type: -

Identifier Source: org_study_id