SepsisNCT04567199
Influence of Cytosorb on Amount of Catecholamine and Mortality in Sepsis
An observational study of Sepsis and Septic Shock, run by Medical University Innsbruck at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Septic Shock, Cytokine Storm
- What is being tested?
- Observational, retrospective
- How many people
- 86 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2018to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- No CytoSorb therapy in patient suspected for sepsis or SIRS (systemic inflammatory response syndrome)
- CytoSorb therapy in patient suspected for sepsis or SIRS
Who cannot join
- no signs of inflammation
- no sepsis
- no SIRS
Trial locations and contacts
1 site in 1 country.
Austria1 site
General and Surgical Critical Care Medicine, Medical University of Innsbruck
Innsbruck, 6020
About this study
Official title: 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.
Read the 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
- Being tested
- Observational, retrospective
- Medical subject headings
- Sepsis, Shock, Septic, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational, retrospectiveOther
retrospective analysis of observed results, for both study groups.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Observational, retrospective |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catecholamine rate over time
Change of Catecholamine rate [µg of catecholamine/kilogram of body weight /minute].
Measured: 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
Length of stay in hospital
Measured: Begin of Sepsis until discharge [up to 54 weeks]
Overall survival
Amount of survivors at discharge
Measured: Begin of Sepsis until discharge [up to 54 weeks]
28 day survival
Amount of survivors at timepoint day 28 [in % of all patients]
Measured: Begin of Sepsis and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Dec 2018
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathias Ströhle, MD, Principal investigator, Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567199
- Sponsor's protocol ID
- 1124/2018
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data regarding the patients condition (lab values, catecholamine need, and other parameters)
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Influence of Cytosorb on Catecholamine Reduction and Mortality in SIRS and Sepsis
- ClinicalTrials.gov ID
- NCT04567199
- Acronym / sponsor ID
- 1124/2018
- Conditions
- Sepsis, Septic Shock, Cytokine Storm, Cytokine Release Syndrome, Catecholamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytosorb recipients | – | Other: Observational, retrospectivePatients 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 |
| Non Cytosorb recipients | – | Other: Observational, retrospectivePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- No CytoSorb therapy in patient suspected for sepsis or SIRS (systemic inflammatory response syndrome)
- CytoSorb therapy in patient suspected for sepsis or SIRS
Key exclusion criteria (3 listed)
- no signs of inflammation
- no sepsis
- no SIRS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational, retrospectiveretrospective analysis of observed results, for both study groups. | Other | Cytosorb recipients, Non Cytosorb recipients |
Primary outcome
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].
3 secondary outcomes
Length of stay
Time frame: Begin of Sepsis until discharge [up to 54 weeks]
Overall survival
Time frame: Begin of Sepsis until discharge [up to 54 weeks]
28 day survival
Time frame: Begin of Sepsis and day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: Undecided. Anonymized data regarding the patients condition (lab values, catecholamine need, and other parameters)
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Ströhle, MD principal investigator
Univ.-Klinik für Allgemeine und Chirurgische Intensivmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.