Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adjuvant Therapy With CytoSorb in Refractory Septic Shock (ACYSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04013269
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
CytoSorbents, Inc
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Condition or disease Intervention/treatment Phase
Septic Shock Device: CytoSorb-Therapy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of the CytoSorb Adsorber on Hemodynamic, Immunological and Pharmacokinetic Parameters in Refractory Septic Shock
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: CytoSorb-Therapy
Therapy of septic shock using guideline directed standard of care, including continuous renal replacement therapy in combination with haemadsorption using CytoSorb-Adsorber
Device: CytoSorb-Therapy
Additional use of Cytosorb-Adsorber in patients with septic shock and need for continuous renal replacement therapy

No Intervention: Standard of care
Therapy of septic shock using guideline directed standard of care, including continuous renal replacement therapy



Primary Outcome Measures :
  1. Percentage of patients with a reduction of catecholamine dose of at least 25% within the first 48 hours of treatment [ Time Frame: 48 hours ]
    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.


Secondary Outcome Measures :
  1. Change in organ dysfunction [ Time Frame: 10 days ]
    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.

  2. Lactate clearance [ Time Frame: 10 days ]
    Improving lactate clearance by lowering serum lactate levels

  3. Renal replacement therapy [ Time Frame: 10 days ]
    Time with need for renal replacement therapy

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

  5. End of septic shock [ Time Frame: 10 days ]
    Time until shock resolution

  6. ICU length of stay [ Time Frame: 90 days ]
    ICU length of stay

  7. Time on mechanical ventilation [ Time Frame: 10 days ]
    Time on mechanical ventilation

  8. Cumulative catecholamine dose [ Time Frame: 10 days ]
    Cumulative catecholamine dose

  9. Overall and ICU mortality [ Time Frame: 90 days ]
    Overall and ICU mortality

  10. Serum levels of administered anti-infectives [ Time Frame: 3 days ]
    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)

  11. Change of plasma Interleukin-6 (IL6) level [ Time Frame: 10 days ]
    Change of plasma Interleukin-6 (IL6) level

  12. Change of plasma Interleukin-10 (IL10) level [ Time Frame: 10 days ]
    Change of plasma Interleukin-10 (IL10) level

  13. Change of plasma Procalcitonin (PCT) level [ Time Frame: 10 days ]
    Change of plasma Procalcitonin (PCT) level

  14. Change of HLA-DR level [ Time Frame: 10 days ]
    Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes

  15. Change of TNF alpha level after ex-vivo stimulation [ Time Frame: 10 days ]
    Change of TNF-alfa level (Tumor Necrosis Factor alpha) level after LPS (Lipopolysaccharides) stimulation as sign of monocytic immunocompetence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013269


Contacts
Layout table for location contacts
Contact: Dominik Jarczak, MD +49 40 741035315 d.jarczak@uke.de
Contact: Axel Nierhaus, MD +49 40 741035315 nierhaus@uke.de

Locations
Layout table for location information
Germany
University Medical Center Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany
Contact: Dominik Jarczak, MD    +49 40 741035315    d.jarczak@uke.de   
Contact: Axel Nierhaus, MD    +49 40 741035315    nierhaus@uke.de   
Principal Investigator: Stefan Kluge, MD         
Sub-Investigator: Dominik Jarczak, MD         
Sub-Investigator: Axel Nierhaus, MD         
Sub-Investigator: Christina König, MD         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
CytoSorbents, Inc
Investigators
Layout table for investigator information
Principal Investigator: Stefan Kluge, MD University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine

Publications:
Layout table for additonal information
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04013269     History of Changes
Other Study ID Numbers: ACYSS
DRKS00015483 ( Registry Identifier: Deutsches Register Klinischer Studien )
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Sepsis
Critically ill
Intensive care medicine
CytoSorb
Hemoadsorption
Pharmacokinetic
Additional relevant MeSH terms:
Layout table for MeSH terms
Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation