Septic ShockNCT04910893
Cytokine Adsorption in Severe, Refractory Septic Shock
A study testing Cytokine Adsorption in people with Septic Shock and Cytokine Storm, run by University of Zurich.
Trial summary
Septic shock and the underlying dysregulated inflammatory host-response remain a major contributor to mortality in critically ill patients. Cytokine adsorption represents an attractive approach to the treatment of septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Cytokine Storm
- What is being tested?
- Cytokine Adsorption
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 27 Nov 2014to 31 Dec 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed septic shock in the 24 hours ensuing diagnosis:
- severe, refractory septic shock defined as:
- an acute SOFA score increase ≥2 points consequent to a presumed or proven infection
- volume resuscitation of at least 30ml/kg in the last 24 hours
- a Vasopressor Dependency Index11 (VPI) above or equal to 3
- a persistently elevated serum lactate level >2mmol/l (II) Interleukin-6 levels equal or above 1000 ng/l (III) were above 18 years of age.
Who cannot join
- Contraindication on ethical grounds
- child bearing or breastfeeding women
- terminal patients
- human immunodeficiency virus with a CD4 cell count <0.2 106/l
- allergy to Polystyrene/ Divinylbenzene, Polycarbonate, Polypropylene, Silicon or Polyester
- need for extra-corporeal membrane oxygenation
- no given consent.
About this study
Septic shock and the underlying dysregulated inflammatory host-response remain a major contributor to mortality in critically ill patients. Cytokine adsorption represents an attractive approach to the treatment of septic shock. Nevertheless, its effect on circulating cytokine levels, as well as on the course of disease remains largely unassessed.
Read the detailed description
Cytokine-release plays an important role in the physiology of immune response to pathologic influences by recruiting immune cells to the pathogenic loci, be they of infectious or of non-infectious nature. Once at the focus, the activated immune cells can in turn release more cytokines if a more extensive immune response is needed. This extremely important mechanism for the organism, can however become pathological if the positive feedback loop between immune cells and cytokines, for any reason, overshoots in form of a so called cytokine storm and substantial amounts of released cytokines gain a systemic influence. The acute complication of this immune over-reaction is a SIRS, which can critically escalate into a potentially lethal multiple organ dysfunction syndrome, thus requiring immediate intensive care treatment.
It is, having this framework in mind, the reason why the CytoSorb-Adsorber has been developed as a new therapeutic milestone. Essentially a haemoperfusion-filter, which through its layering with polymer beads (Divinylbenzene/ Polyvinylpyrrolidone) can adsorb cytokines as well as multiple inflammatory mediators and thus effectively remove them from the bloodstream, reducing their possible systemic influence and hence improving the outcome for patients being treated with it.
The CytoSorb-Adsorber is an already CE-approved product, which has demonstrated its capacity to significantly reduce cytokine-levels such as IL-6, IL-8, IL-10, TNFα, HMGB-1, IL-1ra in a variety of pre-clinical studies. As well as in a clinical randomised multicentre study, which tested the CytoSorb-Adsorber on a cohort of ALI/ ARDS and severely septic/ septically shocked patients. The results of the later study can be very positively assessed, first of all and most importantly showing, that no security concerns had to be had in regard to the haemoperfusion-filter, as no adverse-effects attributable to the device were found. And further, by proving an effect on systemic cytokine-levels in form of a significant reduction in IL-6, IL-8, MCP-1 and IL-1ra, as well as a reduction in mortality of those patients with high initial cytokine levels, effectively reducing the 60 day mortality rate from 60% to 17% in a pool of 14 patients.
With the intention to further elucidate the usefulness and clinical importance of this device this study proposes a prospective recruitment of patients in severe refractory septic shock to test the efficiency of this device.
- Conditions
- Septic Shock, Cytokine Storm
- Being tested
- Cytokine Adsorption, Standard of Care
- Keywords
- Septic Shock, Cytokine Adsorption, Hemadsorption, extracorporeal removal
- Medical subject headings
- Shock, Septic, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine AdsorptionDevice
Also called CytoSorb
Cytokine adsorption therapy will be provided continuously for 72 hours by means of the CytoSorb® (CytoSorbents Corporation, Monmouth Junction, USA) column, run in series to a veno-venous continuous hemodialysis system, which will be exchanged every 24 hours.
Standard of CareOther
Standard intensive care of patients suffering septic shock
| Study group | Role | What they receive |
|---|---|---|
| Cytokine Adsorption Arm | Experimental | Intervention with CytoSorb Receives: Device: Cytokine Adsorption |
| Historical Comparison | Other | Patients extracted from a septic shock population treated at the same institution between 2010 and 2018 and matched to the intervention group. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in circulating Interleukin-6 levels over time
Change in circulating Interleukin-6 levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Measured: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in Vasopressor requirements over time
Change in the Vasopressor Dependency Index, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Measured: Mixed Model Assessment at timepoints 0, 2, 4, 8, 12 , 24, 48, 72 hours
Cumulative intensive care mortality at 30 days
Intensive care mortality assessment at day 30 between groups
Measured: 30 days post fulfillment of inclusion criteria
Secondary outcomes (10)
Change in C-reactive protein levels over time
Change in C-reactive protein levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Measured: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in Procalcitonin levels over time
Change in Procalcitonin levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Measured: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in SOFA Score over time
Change in SOFA Score, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Measured: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in arterial lactate levels over time
Change in arterial lactate levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Measured: Mixed Model Assessment at timepoints 0, 2, 4, 8, 12 , 24, 48, 72 hours
Change in cardiac index over time
Change in cardiac index, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Measured: Mixed Model Assessment at timepoints 0, 2, 4, 8, 12 , 24, 48, 72 hours
Change in Extra Vascular Lung Water Index over time
Change in Extra Vascular Lung Water Index, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Measured: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in daily Infused Volume over time
Change in daily Infused Volume, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Measured: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in PaO2/ FiO2 Ratio over time
Change in PaO2/ FiO2 Ratio, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Measured: Mixed Model Assessment at timepoints 0, 2, 4, 8, 12 , 24, 48, 72 hours
Change in Serum Albumin levels over time
Change in Serum Albumin levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Measured: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in Bilirubin levels over time
Change in Bilirubin levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Measured: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start27 Nov 2014
- Primary completion24 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective interventional study with comparative matched septic shock cohort
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- CytoSorbents Europe GmbH
- Responsible party
- Sponsor
- Investigators
- Marco Maggiorini, MD, Principal investigator, Medizinische Intensivstation D-HOER 27, UniversitatsSpital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910893
- Sponsor's protocol ID
- Cytosorb
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang H, Ma S. The cytokine storm and factors determining the sequence and severity of organ dysfunction in multiple organ dysfunction syndrome. Am J Emerg Med. 2008 Jul;26(6):711-5. doi: 10.1016/j.ajem.2007.10.031.
PubMed 18606328Taniguchi T. Cytokine adsorbing columns. Contrib Nephrol. 2010;166:134-141. doi: 10.1159/000314863. Epub 2010 May 7.
PubMed 20473001Morris C, Gray L, Giovannelli M. Early report: The use of Cytosorb haemabsorption column as an adjunct in managing severe sepsis: initial experiences, review and recommendations. J Intensive Care Soc. 2015 Aug;16(3):257-264. doi: 10.1177/1751143715574855. Epub 2015 Mar 18.
PubMed 28979423Rimmele T, Kellum JA. Clinical review: blood purification for sepsis. Crit Care. 2011;15(1):205. doi: 10.1186/cc9411. Epub 2011 Feb 16.
PubMed 21371356Reiter K, Bordoni V, Dall'Olio G, Ricatti MG, Soli M, Ruperti S, Soffiati G, Galloni E, D'Intini V, Bellomo R, Ronco C. In vitro removal of therapeutic drugs with a novel adsorbent system. Blood Purif. 2002;20(4):380-8. doi: 10.1159/000063108.
PubMed 12169849Kellum JA, Song M, Venkataraman R. Hemoadsorption removes tumor necrosis factor, interleukin-6, and interleukin-10, reduces nuclear factor-kappaB DNA binding, and improves short-term survival in lethal endotoxemia. Crit Care Med. 2004 Mar;32(3):801-5. doi: 10.1097/01.ccm.0000114997.39857.69.
PubMed 15090965Peng ZY, Carter MJ, Kellum JA. Effects of hemoadsorption on cytokine removal and short-term survival in septic rats. Crit Care Med. 2008 May;36(5):1573-7. doi: 10.1097/CCM.0b013e318170b9a7.
PubMed 18434884D Schädler, C Porzelius, A Jörres, G Marx, A Meier-Hellmann, C Putensen, M Quintel, C Spies, C Engel, NWeiler, M Kuhlmann. A multicenter randomized controlled study of an extracorporeal cytokine hemoadsorption device in septic patients. Critical Care 2013, 17(Suppl 2):P62 (19 March 2013).
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Adsorption in Severe, Refractory Septic Shock
- ClinicalTrials.gov ID
- NCT04910893
- Acronym / sponsor ID
- Cytosorb
- Conditions
- Septic Shock, Cytokine Storm
- Keywords
- Septic Shock, Cytokine Adsorption, Hemadsorption, extracorporeal removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- CytoSorbents Europe GmbH
- Study start
- 27 Nov 2014 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Jun 2021 (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.
Septic shock and the underlying dysregulated inflammatory host-response remain a major contributor to mortality in critically ill patients. Cytokine adsorption represents an attractive approach to the treatment of septic shock. Nevertheless, its effect on circulating cytokine levels, as well as on the course of disease remains largely unassessed.
Detailed description
Cytokine-release plays an important role in the physiology of immune response to pathologic influences by recruiting immune cells to the pathogenic loci, be they of infectious or of non-infectious nature. Once at the focus, the activated immune cells can in turn release more cytokines if a more extensive immune response is needed. This extremely important mechanism for the organism, can however become pathological if the positive feedback loop between immune cells and cytokines, for any reason, overshoots in form of a so called cytokine storm and substantial amounts of released cytokines gain a systemic influence. The acute complication of this immune over-reaction is a SIRS, which can critically escalate into a potentially lethal multiple organ dysfunction syndrome, thus requiring immediate intensive care treatment.
It is, having this framework in mind, the reason why the CytoSorb-Adsorber has been developed as a new therapeutic milestone. Essentially a haemoperfusion-filter, which through its layering with polymer beads (Divinylbenzene/ Polyvinylpyrrolidone) can adsorb cytokines as well as multiple inflammatory mediators and thus effectively remove them from the bloodstream, reducing their possible systemic influence and hence improving the outcome for patients being treated with it.
The CytoSorb-Adsorber is an already CE-approved product, which has demonstrated its capacity to significantly reduce cytokine-levels such as IL-6, IL-8, IL-10, TNFα, HMGB-1, IL-1ra in a variety of pre-clinical studies. As well as in a clinical randomised multicentre study, which tested the CytoSorb-Adsorber on a cohort of ALI/ ARDS and severely septic/ septically shocked patients. The results of the later study can be very positively assessed, first of all and most importantly showing, that no security concerns had to be had in regard to the haemoperfusion-filter, as no adverse-effects attributable to the device were found. And further, by proving an effect on systemic cytokine-levels in form of a significant reduction in IL-6, IL-8, MCP-1 and IL-1ra, as well as a reduction in mortality of those patients with high initial cytokine levels, effectively reducing the 60 day mortality rate from 60% to 17% in a pool of 14 patients.
With the intention to further elucidate the usefulness and clinical importance of this device this study proposes a prospective recruitment of patients in severe refractory septic shock to test the efficiency of this device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective interventional study with comparative matched septic shock cohort
| Arm | Type | Receives |
|---|---|---|
| Cytokine Adsorption Arm | Experimental | Device: Cytokine AdsorptionIntervention with CytoSorb |
| Historical Comparison | Other | Other: Standard of CarePatients extracted from a septic shock population treated at the same institution between 2010 and 2018 and matched to the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- severe, refractory septic shock defined as:
- an acute SOFA score increase ≥2 points consequent to a presumed or proven infection
- volume resuscitation of at least 30ml/kg in the last 24 hours
- a Vasopressor Dependency Index11 (VPI) above or equal to 3
- a persistently elevated serum lactate level >2mmol/l (II) Interleukin-6 levels equal or above 1000 ng/l (III) were above 18 years of age.
Key exclusion criteria (7 listed)
- Contraindication on ethical grounds
- child bearing or breastfeeding women
- terminal patients
- human immunodeficiency virus with a CD4 cell count <0.2 106/l
- allergy to Polystyrene/ Divinylbenzene, Polycarbonate, Polypropylene, Silicon or Polyester
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 |
|---|---|---|
| Cytokine AdsorptionAlso: CytoSorbCytokine adsorption therapy will be provided continuously for 72 hours by means of the CytoSorb® (CytoSorbents Corporation, Monmouth Junction, USA) column, run in series to a veno-venous continuous hemodialysis system, which will be exchanged every 24 hours. | Device | Cytokine Adsorption Arm |
| Standard of CareStandard intensive care of patients suffering septic shock | Other | Historical Comparison |
Primary outcome
Change in circulating Interleukin-6 levels over time
Time frame: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in circulating Interleukin-6 levels, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Change in Vasopressor requirements over time
Time frame: Mixed Model Assessment at timepoints 0, 2, 4, 8, 12 , 24, 48, 72 hours
Change in the Vasopressor Dependency Index, stratified by groups, over the initial 72 hours ensuing fulfillment of inclusion criteria
Cumulative intensive care mortality at 30 days
Time frame: 30 days post fulfillment of inclusion criteria
Intensive care mortality assessment at day 30 between groups
10 secondary outcomes
Change in C-reactive protein levels over time
Time frame: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in Procalcitonin levels over time
Time frame: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in SOFA Score over time
Time frame: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in arterial lactate levels over time
Time frame: Mixed Model Assessment at timepoints 0, 2, 4, 8, 12 , 24, 48, 72 hours
Change in cardiac index over time
Time frame: Mixed Model Assessment at timepoints 0, 2, 4, 8, 12 , 24, 48, 72 hours
Change in Extra Vascular Lung Water Index over time
Time frame: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in daily Infused Volume over time
Time frame: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in PaO2/ FiO2 Ratio over time
Time frame: Mixed Model Assessment at timepoints 0, 2, 4, 8, 12 , 24, 48, 72 hours
Change in Serum Albumin levels over time
Time frame: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
Change in Bilirubin levels over time
Time frame: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours
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 10 Jun 2021.
- Background: PubMed 18606328Wang H, Ma S. The cytokine storm and factors determining the sequence and severity of organ dysfunction in multiple organ dysfunction syndrome. Am J Emerg Med. 2008 Jul;26(6):711-5. doi: 10.1016/j.ajem.2007.10.031.
- Background: PubMed 20473001Taniguchi T. Cytokine adsorbing columns. Contrib Nephrol. 2010;166:134-141. doi: 10.1159/000314863. Epub 2010 May 7.
- Background: PubMed 28979423Morris C, Gray L, Giovannelli M. Early report: The use of Cytosorb haemabsorption column as an adjunct in managing severe sepsis: initial experiences, review and recommendations. J Intensive Care Soc. 2015 Aug;16(3):257-264. doi: 10.1177/1751143715574855. Epub 2015 Mar 18.
- Background: PubMed 21371356Rimmele T, Kellum JA. Clinical review: blood purification for sepsis. Crit Care. 2011;15(1):205. doi: 10.1186/cc9411. Epub 2011 Feb 16.
- Background: PubMed 12169849Reiter K, Bordoni V, Dall'Olio G, Ricatti MG, Soli M, Ruperti S, Soffiati G, Galloni E, D'Intini V, Bellomo R, Ronco C. In vitro removal of therapeutic drugs with a novel adsorbent system. Blood Purif. 2002;20(4):380-8. doi: 10.1159/000063108.
- Background: PubMed 15090965Kellum JA, Song M, Venkataraman R. Hemoadsorption removes tumor necrosis factor, interleukin-6, and interleukin-10, reduces nuclear factor-kappaB DNA binding, and improves short-term survival in lethal endotoxemia. Crit Care Med. 2004 Mar;32(3):801-5. doi: 10.1097/01.ccm.0000114997.39857.69.
- Background: PubMed 18434884Peng ZY, Carter MJ, Kellum JA. Effects of hemoadsorption on cytokine removal and short-term survival in septic rats. Crit Care Med. 2008 May;36(5):1573-7. doi: 10.1097/CCM.0b013e318170b9a7.
- BackgroundD Schädler, C Porzelius, A Jörres, G Marx, A Meier-Hellmann, C Putensen, M Quintel, C Spies, C Engel, NWeiler, M Kuhlmann. A multicenter randomized controlled study of an extracorporeal cytokine hemoadsorption device in septic patients. Critical Care 2013, 17(Suppl 2):P62 (19 March 2013).
- Individual participant dataSharing planned: No
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Septic Shock
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.
Marco Maggiorini, MD principal investigator
Medizinische Intensivstation D-HOER 27, UniversitatsSpital Zürich
Questions about this trial
What is this clinical trial studying?
A study testing Cytokine Adsorption in people with Septic Shock and Cytokine Storm, run by University of Zurich.
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 6 inclusion and 7 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 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in circulating Interleukin-6 levels over time (time frame: Mixed Model Assessment at timepoints 0, 24, 48, 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04910893, which also lists 8 linked publications.
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 10 Jun 2021.