Background:The CytOSorb^(R)treatMent Of critically ill patientS(COSMOS)registry is an observational,prospective,multicenter,international real-world data collection platform executed in countries where the CytoSorb^(R...Background:The CytOSorb^(R)treatMent Of critically ill patientS(COSMOS)registry is an observational,prospective,multicenter,international real-world data collection platform executed in countries where the CytoSorb^(R)(CS)300 mL device is approved and routinely used in everyday clinical practice.This study aims to investigate utilization patterns of the hemoadsorption device and associated outcomes in critical care.Methods:Since July 2022,patients who were treated with CS as part of their intensive care treatment were enrolled from 16 sites in Germany,Italy,and Spain in the registry.After informed consent,real-world clinical data are systematically collected at multiple intervals,including 24 h before CS start,during CS treatment,and 24 h post-CS treatment,as well as at discharge from intensive care unit(ICU)and hospital discharge,and final follow-up on day 90.Vital status was assessed as ICU survival,30-day survival,overall hospital survival,and 90-day survival.We compared details on the type of extracorporeal circuit used,device flow rate,anticoagulation regimen,vasopressor requirements,fluid balance,ratio of partial pressure of oxygen in arterial blood to the fraction of inspiratory oxygen concentration(P/F ratio),myoglobin in the rhabdomyolysis cohort and bilirubin in the liver failure cohort before and after CS treatment.Safety of the device was assessed by investigator-reported device-related adverse effects.Data were presented as either mean±standard deviation or as median with interquartile range(IQR).Results:A total of 150 patients were enrolled,23 patients did not have any data entry by the time of the data readout for this interim analysis conducted and therefore had to be excluded from the analysis(33%female,mean age[59±17]years).CS indications included septic shock(57.6%),cardiogenic shock(12.9%),and rhabdomyolysis(10.6%).CS was mainly integrated with renal replacement therapy(82.8%).Median Acute Physiology and Chronic Health Evaluation II score was 23(IQR:17-29),Sequential Organ Failure Assessment score 12(IQR:9-15),and ICU stay 20(IQR:11-33)days.Median interleukin-6 decreased significantly from 862.4(IQR:142-97,457)pg/mL in the 24 h before CS treatment to 202.8(IQR:42-3247)pg/mL in the 24 h post-CS treatment(P<0.0001).Post-CS,lactate and creatinine levels significantly decreased,fluid balance improved from 1386(IQR:220-3168)mL to 275(IQR:-768-1846)mL(P<0.0001)and median P/F ratio increased from 132(IQR:68-208)mmHg to 189(IQR:115-260)mmHg(P<0.0001).Norepinephrine requirements reduced from 0.30(IQR:0.18-0.46)μg/(kg·min)to 0.19(IQR:0.10-0.33)μg/(kg·min)(P=0.0003).In rhabdomyolysis patients,myoglobin decreased from 18,976(IQR:1934-34,275)to 835(IQR:623-5925)μg/L(P=0.0273).Observed ICU mortality was 35%,lower than predicted by baseline scores.Conclusions:The COSMOS registry highlights CS-associated improvements in lactate,creatinine,norepinephrine needs,fluid balance,and oxygenation.Mortality was favorable compared with risk-based predictions.展开更多
BACKGROUND Despite various therapies to treat sepsis,it is one of the leading causes of mortality in the intensive care unit patients globally.Knowledge about the pathophysiology of sepsis has sparked interest in extr...BACKGROUND Despite various therapies to treat sepsis,it is one of the leading causes of mortality in the intensive care unit patients globally.Knowledge about the pathophysiology of sepsis has sparked interest in extracorporeal therapies(ECT)which are intended to balance the dysregulation of the immune system by removing excessive levels of inflammatory mediators.AIM To review recent data on the use of ECT in sepsis and to assess their effects on various inflammatory and clinical outcomes.METHODS In this review,an extensive English literature search was conducted from the last two decades to identify the use of ECT in sepsis.A total of 68 articles from peer-reviewed and indexed journals were selected excluding publications with only abstracts.RESULTS Results showed that ECT techniques such as high-volume hemofiltration,coupled plasma adsorption/filtration,resin or polymer adsorbers,and CytoSorb®are emerging as adjunct therapies to improve hemodynamic stability in sepsis.CytoSorb®has the most published data in regard to the use in the field of septic shock with reports on improved survival rates and lowered sequential organ failure assessment scores,lactate levels,total leucocyte count,platelet count,interleukin-IL-6,IL-10,and TNF levels.CONCLUSION Clinical acceptance of ECT in sepsis and septic shock is currently still limited due to a lack of large random clinical trials.In addition to patient-tailored therapies,future research developments with therapies targeting the cellular level of the immune response are expected.展开更多
BACKGROUND Septic shock is a severe form of sepsis characterised by deterioration in circulatory and cellular-metabolic parameters.Despite standard therapy,the outcomes are poor.Newer adjuvant therapy,such as CytoSorb...BACKGROUND Septic shock is a severe form of sepsis characterised by deterioration in circulatory and cellular-metabolic parameters.Despite standard therapy,the outcomes are poor.Newer adjuvant therapy,such as CytoSorb®extracorporeal haemoadsorption device,has been investigated and shown promising outcome.However,there is a lack of some guidance to make clinical decisions on the use of CytoSorb®haemoadsorption as an adjuvant therapy in septic shock in Indian Setting.Therefore,this expert consensus was formulated.AIM To formulate/establish specific consensus statements on the use of CytoSorb®haemoadsorption treatment based on the best available evidence and contextualised to the Indian scenario.METHODS We performed a comprehensive literature on CytoSorb®haemoadsorption in sepsis,septic shock in PubMed selecting papers published between January 2011 and March 20232021 in English language.The statements for a consensus document were developed based on the summarised literature analysis and identification of knowledge gaps.Using a modified Delphi approach combining evidence appraisal and expert opinion,the following topics related to CytoSorb®in septic shock were addressed:need for adjuvant therapy,initiation timeline,need for Interleukin-6 levels,duration of therapy,change of adsorbers,safety,prerequisite condition,efficacy endpoints and management flowchart.Eleven expert members from critical care,emergency medicine,and the intensive care participated and voted on nine statements and one open-ended question.RESULTS Eleven expert members from critical care,emergency medicine,and the intensive care participated and voted on nine statements and one open-ended question.All 11 experts in the consensus group(100%)participated in the first,second and third round of voting.After three iterative voting rounds and adapting two statements,consensus was achieved on nine statements out of nine statements.The consensus expert panel also recognised the necessity to form an association or society that can keep a registry regarding the use of CytoSorb®for all indications in the open-ended question(Q10)focusing on“future recommendations for CytoSorb®therapy”.CONCLUSION This Indian perspective consensus statement supports and provides guidance on the use of CytoSorb®haemoadsorption as an adjuvant treatment in patients with septic shock to achieve optimal outcomes.展开更多
基金This study was supported by funds from CytoSorbents Corporation and CytoSorbents Medical Inc.
文摘Background:The CytOSorb^(R)treatMent Of critically ill patientS(COSMOS)registry is an observational,prospective,multicenter,international real-world data collection platform executed in countries where the CytoSorb^(R)(CS)300 mL device is approved and routinely used in everyday clinical practice.This study aims to investigate utilization patterns of the hemoadsorption device and associated outcomes in critical care.Methods:Since July 2022,patients who were treated with CS as part of their intensive care treatment were enrolled from 16 sites in Germany,Italy,and Spain in the registry.After informed consent,real-world clinical data are systematically collected at multiple intervals,including 24 h before CS start,during CS treatment,and 24 h post-CS treatment,as well as at discharge from intensive care unit(ICU)and hospital discharge,and final follow-up on day 90.Vital status was assessed as ICU survival,30-day survival,overall hospital survival,and 90-day survival.We compared details on the type of extracorporeal circuit used,device flow rate,anticoagulation regimen,vasopressor requirements,fluid balance,ratio of partial pressure of oxygen in arterial blood to the fraction of inspiratory oxygen concentration(P/F ratio),myoglobin in the rhabdomyolysis cohort and bilirubin in the liver failure cohort before and after CS treatment.Safety of the device was assessed by investigator-reported device-related adverse effects.Data were presented as either mean±standard deviation or as median with interquartile range(IQR).Results:A total of 150 patients were enrolled,23 patients did not have any data entry by the time of the data readout for this interim analysis conducted and therefore had to be excluded from the analysis(33%female,mean age[59±17]years).CS indications included septic shock(57.6%),cardiogenic shock(12.9%),and rhabdomyolysis(10.6%).CS was mainly integrated with renal replacement therapy(82.8%).Median Acute Physiology and Chronic Health Evaluation II score was 23(IQR:17-29),Sequential Organ Failure Assessment score 12(IQR:9-15),and ICU stay 20(IQR:11-33)days.Median interleukin-6 decreased significantly from 862.4(IQR:142-97,457)pg/mL in the 24 h before CS treatment to 202.8(IQR:42-3247)pg/mL in the 24 h post-CS treatment(P<0.0001).Post-CS,lactate and creatinine levels significantly decreased,fluid balance improved from 1386(IQR:220-3168)mL to 275(IQR:-768-1846)mL(P<0.0001)and median P/F ratio increased from 132(IQR:68-208)mmHg to 189(IQR:115-260)mmHg(P<0.0001).Norepinephrine requirements reduced from 0.30(IQR:0.18-0.46)μg/(kg·min)to 0.19(IQR:0.10-0.33)μg/(kg·min)(P=0.0003).In rhabdomyolysis patients,myoglobin decreased from 18,976(IQR:1934-34,275)to 835(IQR:623-5925)μg/L(P=0.0273).Observed ICU mortality was 35%,lower than predicted by baseline scores.Conclusions:The COSMOS registry highlights CS-associated improvements in lactate,creatinine,norepinephrine needs,fluid balance,and oxygenation.Mortality was favorable compared with risk-based predictions.
文摘BACKGROUND Despite various therapies to treat sepsis,it is one of the leading causes of mortality in the intensive care unit patients globally.Knowledge about the pathophysiology of sepsis has sparked interest in extracorporeal therapies(ECT)which are intended to balance the dysregulation of the immune system by removing excessive levels of inflammatory mediators.AIM To review recent data on the use of ECT in sepsis and to assess their effects on various inflammatory and clinical outcomes.METHODS In this review,an extensive English literature search was conducted from the last two decades to identify the use of ECT in sepsis.A total of 68 articles from peer-reviewed and indexed journals were selected excluding publications with only abstracts.RESULTS Results showed that ECT techniques such as high-volume hemofiltration,coupled plasma adsorption/filtration,resin or polymer adsorbers,and CytoSorb®are emerging as adjunct therapies to improve hemodynamic stability in sepsis.CytoSorb®has the most published data in regard to the use in the field of septic shock with reports on improved survival rates and lowered sequential organ failure assessment scores,lactate levels,total leucocyte count,platelet count,interleukin-IL-6,IL-10,and TNF levels.CONCLUSION Clinical acceptance of ECT in sepsis and septic shock is currently still limited due to a lack of large random clinical trials.In addition to patient-tailored therapies,future research developments with therapies targeting the cellular level of the immune response are expected.
文摘BACKGROUND Septic shock is a severe form of sepsis characterised by deterioration in circulatory and cellular-metabolic parameters.Despite standard therapy,the outcomes are poor.Newer adjuvant therapy,such as CytoSorb®extracorporeal haemoadsorption device,has been investigated and shown promising outcome.However,there is a lack of some guidance to make clinical decisions on the use of CytoSorb®haemoadsorption as an adjuvant therapy in septic shock in Indian Setting.Therefore,this expert consensus was formulated.AIM To formulate/establish specific consensus statements on the use of CytoSorb®haemoadsorption treatment based on the best available evidence and contextualised to the Indian scenario.METHODS We performed a comprehensive literature on CytoSorb®haemoadsorption in sepsis,septic shock in PubMed selecting papers published between January 2011 and March 20232021 in English language.The statements for a consensus document were developed based on the summarised literature analysis and identification of knowledge gaps.Using a modified Delphi approach combining evidence appraisal and expert opinion,the following topics related to CytoSorb®in septic shock were addressed:need for adjuvant therapy,initiation timeline,need for Interleukin-6 levels,duration of therapy,change of adsorbers,safety,prerequisite condition,efficacy endpoints and management flowchart.Eleven expert members from critical care,emergency medicine,and the intensive care participated and voted on nine statements and one open-ended question.RESULTS Eleven expert members from critical care,emergency medicine,and the intensive care participated and voted on nine statements and one open-ended question.All 11 experts in the consensus group(100%)participated in the first,second and third round of voting.After three iterative voting rounds and adapting two statements,consensus was achieved on nine statements out of nine statements.The consensus expert panel also recognised the necessity to form an association or society that can keep a registry regarding the use of CytoSorb®for all indications in the open-ended question(Q10)focusing on“future recommendations for CytoSorb®therapy”.CONCLUSION This Indian perspective consensus statement supports and provides guidance on the use of CytoSorb®haemoadsorption as an adjuvant treatment in patients with septic shock to achieve optimal outcomes.
