A Phase 3 interventional study of Standard medical therapy and Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours in Septic Shock, sponsored by University of Pecs. Suspended at 1 site in Hungary. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by University of Pecs · Phase 3, Interventional, and Treatment
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).
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's planned enrollment of 135 is above the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →University of Pecs is the lead sponsor of 100 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized to standard medical therapy.
Combination Product: Standard medical therapy
Patients randomized to cytokine removal therapy with Cytosorb, with the adsorber device changed in every 12 hours.
Device: Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours
Patients randomized to cytokine removal therapy with Cytosorb, with the adsorber device changed in every 24 hours.
Device: Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 24 hours
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.
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.
The standard medical therapy and method of Cytosorb treatment as detailed above will be applied. Adsorber cartridges will be changed in every 24 hours.
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 frame: At the time of shock reversal assessed up to 5 days
Time to shock reversal
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
Procalcitonine level
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
Change in procalcitonine level
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
Interleukin-6 level
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
Change in interleukin-6 level
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
C-reactive protein level
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
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
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
Interleukin-1 level
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
Change in interleukin-1 level
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
Interleukin-1ra level
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
Change in interleukin-1ra level
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
Interleukin-8 level
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
Change in interleukin-8 level
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
Interleukin-10 level
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
Change in interleukin-10 level
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
Tumor necrosis factor alpha level
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
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
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
Syndecan-1 level
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
Change in syndecan-1 level
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
Heparan sulphate level
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
Change in heparan sulphate level
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
Arterial lactate levels
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
Change in arterial lactate levels level
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
Change in SOFA score
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
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
Time frame: From the start of the treatment until the end of the treatment assessed up to 5 days
Duration of mechanical ventilation
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
Duration of catecholamine requirement
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
Duration of renal replacement therapy
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
Need for dialysis
Rate of patients, who require dialysis
Time frame: day 28±7, day 90±7
Length of internsive care unit stay
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
Length of hospital stay
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
Survival
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
Adverse events
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
Plan to share: No
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