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Septic ShockACYSSNCT04013269

Adjuvant Therapy With CytoSorb in Refractory Septic Shock

A study testing CytoSorb-Therapy in people with Septic Shock, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This prospective randomized single center study investigates to what extent the removal of elevated cytokine levels by hemoadsorption has a positive effect on the treatment of patients in septic shock by stabilizing the circulatory situation. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Septic Shock
What is being tested?
CytoSorb-Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteGermany
Study dates
1 Jan 2020to Dec 2023
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Refractory septic shock
  • Need for Norepinephrine ≥ 0.25 µg/kg/min
  • IL6 ≥ 1000 ng/l
  • Indication for CRRT

Who cannot join

  • Sepsis due to pulmonary or urogenital causes
  • Onset of septic shock longer than 36 hours
  • Liver cirrhosis Child Pugh C
  • "do not resuscitate"-order
  • expected survival < 14 days
  • participation in another interventional trial
  • Pregnancy or breastfeeding
  • Lack of consent

Trial locations and contacts

1 site in 1 country.

Dominik Jarczak, MD contact

+49 40 741035315

d.jarczak@uke.de

Axel Nierhaus, MD contact

+49 40 741035315

nierhaus@uke.de

Germany1 site, 1 recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg

    Dominik Jarczak, MD, +49 40 741035315, d.jarczak@uke.de

    Axel Nierhaus, MD, +49 40 741035315, nierhaus@uke.de

    Recruiting

Other trials in Germany

About this study

Official title: Effect of the CytoSorb Adsorber on Hemodynamic, Immunological and Pharmacokinetic Parameters in Refractory Septic Shock

This prospective randomized single center study investigates to what extent the removal of elevated cytokine levels by hemoadsorption has a positive effect on the treatment of patients in septic shock by stabilizing the circulatory situation.

Read the detailed description

The term "sepsis" refers to a clinical syndrome in which a dysregulation of the host's inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. Sepsis and septic shock are major causes of death in intensive care units worldwide.

The clinical picture of septic shock, the most severe form of sepsis, leads to uncontrolled production and release of a large number of proinflammatory cytokines and mediators, the "cytokine storm". Septic shock is accompanied by a massive increase in mortality of up to 60%.

This high mortality rate is due to a lack of current treatment options. The early recognition of the disease and its immediate treatment are decisive for successful therapy and the survival of those affected. The most important therapeutic steps, apart from focus control by antibiotics and surgical intervention, are the stabilization of the affected organ systems, in particular the circulatory system and the respiratory system. As an extracorporeal and non-specific procedure for the interruption of the cytokine storm, hemoadsorption by means of CytoSorb adsorbers may be an intervention, which has already demonstrated its basic effectiveness in the treatment of septic and cardiosurgical patients.

Conditions
Septic Shock
Being tested
CytoSorb-Therapy
Keywords
Sepsis, Critically ill, Intensive care medicine, CytoSorb, Hemoadsorption, Pharmacokinetic
Medical subject headings
Shock, Septic, Sepsis, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CytoSorb-TherapyDevice

    Additional use of Cytosorb-Adsorber in patients with septic shock and need for continuous renal replacement therapy

Study groups in NCT04013269
Study groupRoleWhat they receive
CytoSorb-TherapyActive comparatorTherapy of septic shock using guideline directed standard of care, including continuous renal replacement therapy in combination with haemadsorption using CytoSorb-Adsorber
Receives: Device: CytoSorb-Therapy
Standard of careNo interventionTherapy of septic shock using guideline directed standard of care, including continuous renal replacement therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with a reduction of catecholamine dose of at least 25% within the first 48 hours of treatment

    Percentage of patients with a reduction of catecholamine dose of at least 25% compared to baseline for at least 6 hours within the first 48 hours of treatment.

    Measured: 48 hours

Secondary outcomes (15)

  1. Change in organ dysfunction

    Change in organ dysfunction based on "Sequential Organ Failure Assessment" (SOFA) Score The SOFA score is made of 6 variables, each representing an organ system. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure) The worst physiological variables were collected serially every 24 hours of a patient's ICU admission. The "worst" measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24.

    Measured: 10 days

  2. Lactate clearance

    Improving lactate clearance by lowering serum lactate levels

    Measured: 10 days

  3. Renal replacement therapy

    Time with need for renal replacement therapy

    Measured: 10 days

  4. Percentage of patients with a reduction of catecholamine dose of at least 25% within the first 24 hours of treatment

    Percentage of patients with a reduction of catecholamine dose of at least 25% compared to baseline for at least 6 hours within the first 48 hours of treatment.

    Measured: 24 hours

  5. End of septic shock

    Time until shock resolution

    Measured: 10 days

  6. ICU length of stay

    ICU length of stay

    Measured: 90 days

  7. Time on mechanical ventilation

    Time on mechanical ventilation

    Measured: 10 days

  8. Cumulative catecholamine dose

    Cumulative catecholamine dose

    Measured: 10 days

  9. Overall and ICU mortality

    Overall and ICU mortality

    Measured: 90 days

  10. Serum levels of administered anti-infectives

    Serum drug Levels of pre and post filter and adsorber system on day 1-3 while CytoSorb therapy (sampling: t 0, 1, 2, 6, 8, 12, 24 h after CytoSorb initiation)

    Measured: 3 days

  11. Change of plasma Interleukin-6 (IL6) level

    Change of plasma Interleukin-6 (IL6) level

    Measured: 10 days

  12. Change of plasma Interleukin-10 (IL10) level

    Change of plasma Interleukin-10 (IL10) level

    Measured: 10 days

  13. Change of plasma Procalcitonin (PCT) level

    Change of plasma Procalcitonin (PCT) level

    Measured: 10 days

  14. Change of HLA-DR level

    Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes

    Measured: 10 days

  15. Change of TNF alpha level after ex-vivo stimulation

    Change of TNF-alfa level (Tumor Necrosis Factor alpha) level after LPS (Lipopolysaccharides) stimulation as sign of monocytic immunocompetence

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2019
  2. Study start1 Jan 2020
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04013269
Sponsor's protocol ID
ACYSS
Other IDs
DRKS00015483
Acronym
ACYSS
Status last verified
Nov 2022
First submitted
15 Jun 2019
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Taeb AM, Hooper MH, Marik PE. Sepsis: Current Definition, Pathophysiology, Diagnosis, and Management. Nutr Clin Pract. 2017 Jun;32(3):296-308. doi: 10.1177/0884533617695243. Epub 2017 Mar 17.

    PubMed 28537517

  • Friesecke S, Stecher SS, Gross S, Felix SB, Nierhaus A. Extracorporeal cytokine elimination as rescue therapy in refractory septic shock: a prospective single-center study. J Artif Organs. 2017 Sep;20(3):252-259. doi: 10.1007/s10047-017-0967-4. Epub 2017 Jun 6.

    PubMed 28589286

  • Garau I, Marz A, Sehner S, Reuter DA, Reichenspurner H, Zollner C, Kubitz JC. Hemadsorption during cardiopulmonary bypass reduces interleukin 8 and tumor necrosis factor alpha serum levels in cardiac surgery: a randomized controlled trial. Minerva Anestesiol. 2019 Jul;85(7):715-723. doi: 10.23736/S0375-9393.18.12898-7. Epub 2018 Nov 22.

    PubMed 30481999

  • Kogelmann K, Jarczak D, Scheller M, Druner M. Hemoadsorption by CytoSorb in septic patients: a case series. Crit Care. 2017 Mar 27;21(1):74. doi: 10.1186/s13054-017-1662-9.

    PubMed 28343448

  • Bayer O, Reinhart K, Kohl M, Kabisch B, Marshall J, Sakr Y, Bauer M, Hartog C, Schwarzkopf D, Riedemann N. Effects of fluid resuscitation with synthetic colloids or crystalloids alone on shock reversal, fluid balance, and patient outcomes in patients with severe sepsis: a prospective sequential analysis. Crit Care Med. 2012 Sep;40(9):2543-51. doi: 10.1097/CCM.0b013e318258fee7.

    PubMed 22903091

Questions about this trial

What is this clinical trial studying?

A study testing CytoSorb-Therapy in people with Septic Shock, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Nov 2022. 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 Germany. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dominik Jarczak, MD (+49 40 741035315, d.jarczak@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with a reduction of catecholamine dose of at least 25% within the first 48 hours of treatment (time frame: 48 hours). 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 NCT04013269, which also lists 5 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 8 Nov 2022.

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ACYSS Clinical Trial NCT04013269 | AzTrials