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Extracorporeal cell therapy of septic shock patients with donor granulocytes a pilot study.doc

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Extracorporeal cell therapy of septic shock patients with donor granulocytes a pilot study

Altrichteretal.CriticalCare2011,15:R82 /content/15/2/R82 RESEARCH OpenAccess Extracorporealcelltherapyofsepticshock patientswithdonorgranulocytes:apilotstudy JensAltrichter1,MartinSauer2,KatharinaKaftan1,ThomasBirken2,DorisGloger3,MartinGloger4,J?rgHenschel4, HeikoHickstein1,ErnstKlar5,SebastianKoball1,AnnettePertschy5,GabrieleN?ldge-Schomburg2, DierkAVagts2andSteffenRMitzner1* Abstract Introduction:Neutrophilgranulocytesarethefirstdefenselineinbacterialinfections.However,granulocytesare alsoresponsibleforseverelocaltissueimpairment.Inordertousedonorgranulocytes,butatthesametimeto avoidlocalsideeffects,wedevelopedanextracorporealimmunesupportsystem.Thisfirst-in-manstudy investigatedwhetheranextracorporealplasmatreatmentwithagranulocytebioreactoristolerableinpatientswith septicshock.Afurtherintentionwastofindsuitableefficacyend-pointsforsubsequentcontrolledtrials. Methods:ThetrialwasconductedasaprospectiveuncontrolledclinicalphaseI/IIstudywith28-dayfollow-upat threeuniversityhospitalintensivecareunits.Tenconsecutivepatients(fivemen,fivewomen,meanage60.3± 13.9standarddeviation(SD)years)withsepticshockwithmeanICUentrancescoresofAcutePhysiologyand ChronicHealthEvaluation(APACHE)IIof29.9±7.2andofSimplifiedAcutePhysiologyScore(SAPS)IIof66.2± 19.5weretreatedtwicewithin72hoursforameanof342±64minutes/treatmentwithanextracorporeal bioreactorcontaining1.41±0.43×10E10granulocytesfromhealthydonors.Onaverage,9.8±2.3litersseparated plasmaweretreatedbythetherapeuticdonorcells.Patientswerefollowedupfor28days. Results:Toleranceandtechnicalsafetyduringtreatment,singleorganfunctionspre/posttreatment,andhospital survivalweremonitored.Theextracorporealtreatmentswerewelltolerated.Duringthetreatments,thebacterial endotoxinconcentrationshowedsignificantreduction.Furthermore,noradrenalinedosagecouldbesignificantly reducedwhilemeanarterialpressurewasstable.Also,C-reactiveprotein,procalcitonin,andhumanleukocyte antigenDR(HLA-DR)showedsignificantimprovement.Fourpatientsdiedinthehospitalondays