Influence of Cytosorb on Amount of Catecholamine and Mortality in Sepsis

NCT04567199 | Completed

• 1 other identifier: 1124/2018
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Length of stay

  Begin of Sepsis until discharge [up to 54 weeks]

• Overall survival

  Begin of Sepsis until discharge [up to 54 weeks]

• 28 day survival

  Begin of Sepsis and day 28

Study Arms (2)

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

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

Interventions

Observational, retrospective OTHER

retrospective analysis of observed results, for both study groups.

Cytosorb recipients; Non Cytosorb recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• No CytoSorb therapy in patient suspected for sepsis or SIRS (systemic inflammatory response syndrome)
• CytoSorb therapy in patient suspected for sepsis or SIRS

You may not qualify if:

• no signs of inflammation
• no sepsis
• no SIRS

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

General and Surgical Critical Care Medicine, Medical University of Innsbruck

Innsbruck, 6020, Austria

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic; Cytokine Release Syndrome

Interventions

Retrospective Studies

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Case-Control Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Cohort Studies; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mathias Ströhle, MD

  Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 28, 2020
• Study Start: December 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 3, 2021

Record last verified: 2020-09

Locations

AU (1)