Adjuvant Therapy With CytoSorb in Refractory Septic Shock (ACYSS)
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|ClinicalTrials.gov Identifier: NCT04013269|
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : September 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Device: CytoSorb-Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of the CytoSorb Adsorber on Hemodynamic, Immunological and Pharmacokinetic Parameters in Refractory Septic Shock|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||March 2022|
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
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
- 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.
- 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.
- Lactate clearance [ Time Frame: 10 days ]Improving lactate clearance by lowering serum lactate levels
- Renal replacement therapy [ Time Frame: 10 days ]Time with need for renal replacement therapy
- 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.
- End of septic shock [ Time Frame: 10 days ]Time until shock resolution
- ICU length of stay [ Time Frame: 90 days ]ICU length of stay
- Time on mechanical ventilation [ Time Frame: 10 days ]Time on mechanical ventilation
- Cumulative catecholamine dose [ Time Frame: 10 days ]Cumulative catecholamine dose
- Overall and ICU mortality [ Time Frame: 90 days ]Overall and ICU mortality
- 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)
- Change of plasma Interleukin-6 (IL6) level [ Time Frame: 10 days ]Change of plasma Interleukin-6 (IL6) level
- Change of plasma Interleukin-10 (IL10) level [ Time Frame: 10 days ]Change of plasma Interleukin-10 (IL10) level
- Change of plasma Procalcitonin (PCT) level [ Time Frame: 10 days ]Change of plasma Procalcitonin (PCT) level
- Change of HLA-DR level [ Time Frame: 10 days ]Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes
- 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
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
|Contact: Dominik Jarczak, MD||+49 40 firstname.lastname@example.org|
|Contact: Axel Nierhaus, MD||+49 40 email@example.com|
|University Medical Center Hamburg-Eppendorf|
|Contact: Dominik Jarczak, MD +49 40 741035315 firstname.lastname@example.org|
|Contact: Axel Nierhaus, MD +49 40 741035315 email@example.com|
|Principal Investigator: Stefan Kluge, MD|
|Sub-Investigator: Dominik Jarczak, MD|
|Sub-Investigator: Axel Nierhaus, MD|
|Sub-Investigator: Christina König, MD|
|Principal Investigator:||Stefan Kluge, MD||University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine|