Back to resultsExtracorporal Cytokin Removal in Septic Shock: a Prospective, Randomized, Multicenter Clinical Trial (DECRISS)
Primary Purpose
Septic Shock
Status
Suspended
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
Standard medical therapy
Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours
Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 24 hours
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring sepsis, septic shock, cytosorb, cytokine removal
Eligibility Criteria
Inclusion Criteria:
- Septic shock as defined by the Sepsis-3 criteria
- Septic shock both medical or surgical ethiology (except for re-operation)
- APACHE > 25
- Mechanical ventilation
- Norepinephrine requirement ≥0.4 µg/kg/min for at least 30 minutes, when hypovolemia is highly unlikely as indicated by invasive hemodynamic measurements assessed by the attending physician
- Invasive hemodynamic monitoring to determine cardiac output and derived variables
- Procalcitonin level ≥ 10 ng/ml
- Inclusion within 6 - 24 hours after the onset of vasopressor need and after all standard therapeutic measures have been implemented without clinical improvement (i.e.: the shock is considered refractory)
Exclusion Criteria:
- Patients under 18 years and over 80
- Lack of health insurance
- Pregnancy
- Standard guideline-based medical treatment not exhausted (detailed below at 3.6) standard medical therapy)
- End stage organ failure
- New York Heart Association Class IV.
- Chronic renal failure with eGFR < 15 ml/min/1,73 m2
- End-stage liver disease (MELD score >30, Child-Pugh score Class C
- Unlikely survival for 24 hours according to the attending physician
- Acute onset of hemato-oncological illness
- Post cardiopulmonary resuscitation care
- Re-operation in context with the septic insult
- Immunosuppression
- systemic steroid therapy (>10 mg prednisolon/day)
- immunosuppressive agents (i.e.: methotrexate, azathioprine, cyclosporin, tacrolimus, cyclophosphamide)
- Human immunodeficiency virus infection (active AIDS): HIV-VL > 50 copies/mL
- Patients with transplanted vital organs
- Thrombocytopenia (<20.000/ml)
- More than 10%-of body surface area with a third-degree burn
- Acute coronary syndrome
Sites / Locations
- Institute for Translational Medicine, University of Pécs
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Patients randomized to standard medical therapy.
Patients randomized to cytokine removal therapy with Cytosorb, with the adsorber device changed in every 12 hours.
Patients randomized to cytokine removal therapy with Cytosorb, with the adsorber device changed in every 24 hours.
Outcomes
Primary Outcome Measures
Shock reversal
Proportion of patients achieving shock reversal, defined as follows:
no need (or minimal need, meaning max. the 10% of the maximum dose) of vasopressore for 3 hours, with haemodynamic measurements, and arterial, central venous blood gas analysis, arterial lactate level measurement, venous and arterial pCO2-gap and O2 saturation measurements to confirm cardiorespiratory stability
Time to shock reversal
The time from the start of the treatment (T0) until shock reversal
Secondary Outcome Measures
Procalcitonine level
Absolute level of procalcitonine
Change in procalcitonine level
Change in procalcitonine level from the start of the treatment until the end of the study period
Interleukin-6 level
Absolute level of interleukin-6
Change in interleukin-6 level
Change in interleukin-6 level from the start of the treatment until the end of the study period
C-reactive protein level
Absolute level of C-reactive protein
Change in C-reactive protein level
Change in C-reactive protein level from the start of the treatment until the end of the study period
Interleukin-1 level
Absolute level of interleukin-1
Change in interleukin-1 level
Change in interleukin-1 level from the start of the treatment until the end of the study period
Interleukin-1ra level
Absolute level of interleukin-1ra
Change in interleukin-1ra level
Change in interleukin-1ra level from the start of the treatment until the end of the study period
Interleukin-8 level
Absolute level of interleukin-8
Change in interleukin-8 level
Change in interleukin-8 level from the start of the treatment until the end of the study period
Interleukin-10 level
Absolute level of interleukin-10
Change in interleukin-10 level
Change in interleukin-10 level from the start of the treatment until the end of the study period
Tumor necrosis factor alpha level
Absolute level of tumor necrosis factor alpha
Change in tumor necrosis factor alpha level
Change in tumor necrosis factor alpha level from the start of the treatment until the end of the study period
Syndecan-1 level
Absolute level of syndecan-1
Change in syndecan-1 level
Change in syndecan-1 level from the start of the treatment until the end of the study period
Heparan sulphate level
Absolute level of heparan sulphate
Change in heparan sulphate level
Change in heparan sulphate level from the start of the treatment until the end of the study period
Arterial lactate levels
Absolute level of arterial lactate levels
Change in arterial lactate levels level
Change in arterial lactate level from the start of the treatment until the end of the study period
Change in SOFA score
Change in SOFA score from the start of the treatment until the end of the study period
Change in extravascular lung water (EVLW)
Change in extravascular lung water (EVLW) from the start of the treatment until the end of the study period
Duration of mechanical ventilation
Duration of mechanical ventilation given in days
Duration of catecholamine requirement
Duration of catecholamine requirement given in days
Duration of renal replacement therapy
Duration of renal replacement therapy given in days
Need for dialysis
Rate of patients, who require dialysis
Length of internsive care unit stay
Length of intensive care unit stay given in days
Length of hospital stay
Length of hospital stay given in days
Survival
Rate of surviving patients
Adverse events
Rate of patients experiencing adverse events, or device deficiencies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04742764
Brief Title
Extracorporal Cytokin Removal in Septic Shock: a Prospective, Randomized, Multicenter Clinical Trial
Acronym
DECRISS
Official Title
Dosing of Extracorporeal Cytokine Removal In Septic Shock (DECRISS): a Prospective, Randomized, Multicenter Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
The human resources required to start enrollment were not available anymore.
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
October 31, 2026 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pecs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Sepsis and septic shock have mortality rates between 20-50%. When standard therapeutic measures fail to improve patients' condition, additional therapeutic alternatives are applied to reduce morbidity and mortality. One of the most recent alternatives is extracorporeal cytokine hemoadsorption. One of the most tested devices is CytoSorb, however, there are a lot of open questions, such timing, dosing and of course its overall efficacy. This study aims to compare the efficacy of standard medical therapy (Group A, SMT) and continuous extracorporeal cytokine removal with CytoSorb therapy in patients with early refractory septic shock. Furthermore, we compare the dosing of CytoSorb adsorber device - as the cartridge will be changed in every (12 Group B) or 24 hours (Group C).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
sepsis, septic shock, cytosorb, cytokine removal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, controlled, three-arm, open-label, international, multi-centre, phase III study
Masking
Outcomes Assessor
Masking Description
No masking is applied in this study, as it is impossible to blind the medical personnel and participants. Statisticians will be blinded to allocation
Allocation
Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Patients randomized to standard medical therapy.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Patients randomized to cytokine removal therapy with Cytosorb, with the adsorber device changed in every 12 hours.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Patients randomized to cytokine removal therapy with Cytosorb, with the adsorber device changed in every 24 hours.
Intervention Type
Combination Product
Intervention Name(s)
Standard medical therapy
Intervention Description
Standard medical therapy (according to the Surviving Sepsis Campaign) will include standard monitoring (pulseoximetry, 5-lead ECG, continuous invasive blood pressure monitoring, central venous cannulation and 24 with PiCCO-technology. Norepinephrine as a vasopressor and dobutamine - if needed - as an inotrope will be administered by the attending physician.
Intervention Type
Device
Intervention Name(s)
Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours
Intervention Description
Standard medical therapy, as discussed above will be applied. Furthermore, Cytosorb will be administered as soon as it is possible after randomization but not later than 2 hour (start of the treatment, T0). In a blood pump circuit in pre-haemofilter position, using a kidney replacement device of Fresenius Multifiltrate as a solo therapy or in combination with renal replacement therapy. It will be run in CVVHD, CVVHDF or CVVH mode with a 150 and 200 ml/min blood flow. Anticoagulation will be applied intravenously with heparin, low molecular weight heparin or citrate. The aim of the pump flow rate will be 100-400 mL/min, and the flow rate will be recorded. Possible shock reversal will be assessed by the physician attending. Adsorber cartridges will be changed in every 12 hours. End of the study period (Te): 12 hours after shock reversal, death of the patient, or maximum of five days, whichever happens first.
Intervention Type
Device
Intervention Name(s)
Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 24 hours
Intervention Description
The standard medical therapy and method of Cytosorb treatment as detailed above will be applied. Adsorber cartridges will be changed in every 24 hours.
Primary Outcome Measure Information:
Title
Shock reversal
Description
Proportion of patients achieving shock reversal, defined as follows:
no need (or minimal need, meaning max. the 10% of the maximum dose) of vasopressore for 3 hours, with haemodynamic measurements, and arterial, central venous blood gas analysis, arterial lactate level measurement, venous and arterial pCO2-gap and O2 saturation measurements to confirm cardiorespiratory stability
Time Frame
At the time of shock reversal assessed up to 5 days
Title
Time to shock reversal
Description
The time from the start of the treatment (T0) until shock reversal
Time Frame
From the start of the treatment until shock reversal assessed up to 5 days
Secondary Outcome Measure Information:
Title
Procalcitonine level
Description
Absolute level of procalcitonine
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Change in procalcitonine level
Description
Change in procalcitonine level from the start of the treatment until the end of the study period
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Interleukin-6 level
Description
Absolute level of interleukin-6
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Change in interleukin-6 level
Description
Change in interleukin-6 level from the start of the treatment until the end of the study period
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
C-reactive protein level
Description
Absolute level of C-reactive protein
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Change in C-reactive protein level
Description
Change in C-reactive protein level from the start of the treatment until the end of the study period
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Interleukin-1 level
Description
Absolute level of interleukin-1
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Change in interleukin-1 level
Description
Change in interleukin-1 level from the start of the treatment until the end of the study period
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Interleukin-1ra level
Description
Absolute level of interleukin-1ra
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Change in interleukin-1ra level
Description
Change in interleukin-1ra level from the start of the treatment until the end of the study period
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Interleukin-8 level
Description
Absolute level of interleukin-8
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Change in interleukin-8 level
Description
Change in interleukin-8 level from the start of the treatment until the end of the study period
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Interleukin-10 level
Description
Absolute level of interleukin-10
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Change in interleukin-10 level
Description
Change in interleukin-10 level from the start of the treatment until the end of the study period
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Tumor necrosis factor alpha level
Description
Absolute level of tumor necrosis factor alpha
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Change in tumor necrosis factor alpha level
Description
Change in tumor necrosis factor alpha level from the start of the treatment until the end of the study period
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Syndecan-1 level
Description
Absolute level of syndecan-1
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Change in syndecan-1 level
Description
Change in syndecan-1 level from the start of the treatment until the end of the study period
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Heparan sulphate level
Description
Absolute level of heparan sulphate
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Change in heparan sulphate level
Description
Change in heparan sulphate level from the start of the treatment until the end of the study period
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Arterial lactate levels
Description
Absolute level of arterial lactate levels
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Change in arterial lactate levels level
Description
Change in arterial lactate level from the start of the treatment until the end of the study period
Time Frame
0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit
Title
Change in SOFA score
Description
Change in SOFA score from the start of the treatment until the end of the study period
Time Frame
From the start of the treatment until the end of the treatment assessed up to 5 days
Title
Change in extravascular lung water (EVLW)
Description
Change in extravascular lung water (EVLW) from the start of the treatment until the end of the study period
Time Frame
From the start of the treatment until the end of the treatment assessed up to 5 days
Title
Duration of mechanical ventilation
Description
Duration of mechanical ventilation given in days
Time Frame
From the start of the treatment until the end of the treatment assessed up to 5 days
Title
Duration of catecholamine requirement
Description
Duration of catecholamine requirement given in days
Time Frame
From the start of the catecholamine requirement until the end of the catecholamine requirement assessed up to 5 days
Title
Duration of renal replacement therapy
Description
Duration of renal replacement therapy given in days
Time Frame
From the start of the renal replacement therapy requirement until the end of the renal replacement therapy requirement assessed up to 90+/-7 days at the second follow-up visit
Title
Need for dialysis
Description
Rate of patients, who require dialysis
Time Frame
day 28±7, day 90±7
Title
Length of internsive care unit stay
Description
Length of intensive care unit stay given in days
Time Frame
From admission to intensive care unit until the end of intensive care unit assessed at study completion an avarage of 90 days
Title
Length of hospital stay
Description
Length of hospital stay given in days
Time Frame
From admission to the hospital until the end of hospital stay assessed at study completion an avarage of 90 days
Title
Survival
Description
Rate of surviving patients
Time Frame
Rate if surviving patients assessed at death, or study completion which ever happens first, up to 90 +/-7 days
Title
Adverse events
Description
Rate of patients experiencing adverse events, or device deficiencies
Time Frame
Recorded at the occurrance of adverse events, and study completion up to 90 +/- 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Septic shock as defined by the Sepsis-3 criteria
Septic shock both medical or surgical ethiology (except for re-operation)
APACHE > 25
Mechanical ventilation
Norepinephrine requirement ≥0.4 µg/kg/min for at least 30 minutes, when hypovolemia is highly unlikely as indicated by invasive hemodynamic measurements assessed by the attending physician
Invasive hemodynamic monitoring to determine cardiac output and derived variables
Procalcitonin level ≥ 10 ng/ml
Inclusion within 6 - 24 hours after the onset of vasopressor need and after all standard therapeutic measures have been implemented without clinical improvement (i.e.: the shock is considered refractory)
Exclusion Criteria:
Patients under 18 years and over 80
Lack of health insurance
Pregnancy
Standard guideline-based medical treatment not exhausted (detailed below at 3.6) standard medical therapy)
End stage organ failure
New York Heart Association Class IV.
Chronic renal failure with eGFR < 15 ml/min/1,73 m2
End-stage liver disease (MELD score >30, Child-Pugh score Class C
Unlikely survival for 24 hours according to the attending physician
Acute onset of hemato-oncological illness
Post cardiopulmonary resuscitation care
Re-operation in context with the septic insult
Immunosuppression
systemic steroid therapy (>10 mg prednisolon/day)
immunosuppressive agents (i.e.: methotrexate, azathioprine, cyclosporin, tacrolimus, cyclophosphamide)
Human immunodeficiency virus infection (active AIDS): HIV-VL > 50 copies/mL
Patients with transplanted vital organs
Thrombocytopenia (<20.000/ml)
More than 10%-of body surface area with a third-degree burn
Acute coronary syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Péter Hegyi, MD, PhD, DSc
Organizational Affiliation
Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Translational Medicine, University of Pécs
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
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https://cytosorbents.com/products/cyto-sorb/
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Cytosorbents Corporation CytoSorbents
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Extracorporal Cytokin Removal in Septic Shock: a Prospective, Randomized, Multicenter Clinical Trial
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