[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100400426":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":61,"studyPopulation":54,"armGroups":62,"interventions":73,"overallOfficials":54,"centralContacts":77,"locations":87,"responsibleParty":458,"collaborators":54,"id":460,"slug":461,"hasResults":462,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":54,"eligibilityCriteria":466,"healthyVolunteers":462,"sex":467,"minAge":468,"maxAge":54,"enrollmentInfo":469,"targetDuration":54,"studyType":472,"phases":473,"briefSummary":475,"conditions":476,"keywords":478,"overallStatus":90,"whyStopped":54,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":491},{"fullName":5,"class":6},"Centre Hospitalier Intercommunal Creteil","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"Mortality","All causes mortality","Day 60 from randomization",[14,18,22,25,28,29,33,37,40,43,46,50],{"measure":15,"description":16,"timeFrame":17},"Evolution of SOFA Score","Sequential Organ Failure Assessment (SOFA) score will be calculated at d1, d2, d3 and d7 and compared between the 2 arms.\n\nHiger the score higher the severity of organ dysfunctions. Min 0 Max 24","Up to Day 7",{"measure":19,"description":20,"timeFrame":21},"Number of ventilator free days","Number of free days will be assessed as proposed by YEHYA et al. Patients who died before d28 will be considered as having 0 free day","Day 28",{"measure":23,"description":24,"timeFrame":21},"Number of renal replacement therapy free days","Number of free days will be assessed as proposed by YEHYA et al.",{"measure":26,"description":27,"timeFrame":21},"Number of vasopressor free days","Number of free days will be assessed as proposed by YEHYA et al. Shock resolution will be defined by vasopressor stop during at least 24h in the absence of care withdrawing",{"measure":10,"description":11,"timeFrame":21},{"measure":30,"description":31,"timeFrame":32},"Number of patients with shivering","Shivering will be monitored according to a specific scale","Day 2",{"measure":34,"description":35,"timeFrame":36},"Number of patients with seizure","Seizure will be clinically documented or reveal by EEG","Day 3",{"measure":38,"description":39,"timeFrame":36},"Number of patients with hypothermia","Number of patients with body temperature lower than 36°C",{"measure":41,"description":42,"timeFrame":36},"Number of patients with at least 1 episode of cardiac arrhythmia","Patient with new episode of supraventricular or ventricular arrhythmia",{"measure":44,"description":45,"timeFrame":21},"Secondary acquired nosocomial infections","Only the first episode will be taken into account",{"measure":47,"description":48,"timeFrame":49},"Number of patients with ARDS development among patients free of ARDS at inclusion","Secondary acquired ARDS according to Berlin definition","Up to Day 3",{"measure":51,"description":52,"timeFrame":53},"Acute kidney injury in patients free of RRT at inclusion","Maximal stage of AKI according to the KDIGO definition","Up to Day7",null,{"allocation":56,"interventionModel":57,"interventionModelDescription":54,"primaryPurpose":58,"observationalModel":54,"timePerspective":54,"maskingInfo":59},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":60,"maskingDescription":54,"whoMasked":54},"NONE","Sepsis is a common syndrome responsible for multiple organ failure. Septic shock, defined as sepsis with hyperlactatemia and cardiovascular failure requiring vasopressor infusion despite adequate fluid resuscitation has an extremely high mortality rate. Fever is a frequent disease process during sepsis. Fever increases oxygen consumption and can worsen imbalance between oxygen supply and oxygen requirements. Fever increases inflammation but reduces viral and bacterial growth. The beneficial effects of active fever control on inflammation have been mainly shown in a context of lung injury. Pneumonia represents the first cause of septic shock in developed countries.\n\nIn a pilot study (SEPSISCOOL I), we showed that fever treatment using external cooling significantly increased the resolution of shock, improved organ functions and decreased d-14 mortality. Although reduced, hospital mortality was not significantly different. This study was underpowered to allow conclusion on mortality. A more pronounced beneficial effect was observed among the most severely ill patients with elevated serum lactate level.\n\nFever treatment is commonly applied in septic patients but its impact on survival remains undetermined.\n\nThe main objective of the study is to compare two strategies of fever management in febrile (body temperature \\> 38.3°C) septic shock patients requiring invasive mechanical ventilation and sedation. These patients will be randomly allocated in two arms:\n\n1. Fever respect\n2. Fever control by external cooling to obtain normothermia during 48 hours\n\nA covariate-adaptive randomization will be used to ensure the comparability of the two groups at each stage of the study. We will use an adaptive multistage population-enrichment design with a pre-specified subgroup of patients with ARDS identified at randomization.\n\nAn independent Safety and Data Monitoring Committee will review data on serious adverse events. The decision of study stop for potential harmful effect of one strategy will be let at the entire responsibility of the committee.\n\nOne interim analysis will be performed by independent observers after enrolment of half of the population. The assumption that fever treatment is more effective in patients with ARDS will be confirmed or not. According to pre-defined rules based on the conditional power calculated in the two subgroups, the trial will be stopped for futility, continued as planned or continued by enrolling only patients with ARDS.",[63,69],{"label":64,"type":65,"description":66,"interventionNames":67},"Fever Control by external cooling","EXPERIMENTAL","External cooling during 48 hours to obtain normothermia",[68],"Other: External Cooling",{"label":70,"type":71,"description":72,"interventionNames":54},"Fever respected, no cooling","NO_INTERVENTION","Fever respect without any antipyretic therapy",[74],{"type":6,"name":75,"description":75,"armGroupLabels":76,"otherNames":54},"External Cooling",[64],[78,83],{"name":79,"role":80,"phone":81,"phoneExt":54,"email":82},"Frédérique SCHORTGEN, MD","CONTACT","01 57 02 34 11","Frederique.schortgen@chicreteil.fr",{"name":84,"role":80,"phone":85,"phoneExt":54,"email":86},"Camille JUNG, MD","01 57 02 22 68","camille.jung@chicreteil.fr",[88,104,116,128,140,152,163,169,181,193,205,217,225,237,250,262,275,284,292,304,316,328,336,345,357,366,378,386,398,410,422,434,446],{"facility":89,"status":90,"city":91,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"CHU Amiens","RECRUITING","Amiens","France","FR",{"type":95,"coordinates":96},"Point",[97,98],2.3,49.9,{"lat":98,"lon":97},[101],{"name":102,"role":80,"phone":54,"phoneExt":54,"email":103},"Julien MAIZEL, MD","Maizel.Julien@chu-amiens.fr",{"facility":105,"status":90,"city":106,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"CHU Angers","Angers",{"type":95,"coordinates":108},[109,110],-0.55202,47.47156,{"lat":110,"lon":109},[113],{"name":114,"role":80,"phone":54,"phoneExt":54,"email":115},"ASFAR Pierre, MD","PiAsfar@chu-angers.fr",{"facility":117,"status":90,"city":118,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"CH Victor Dupouy","Argenteuil",{"type":95,"coordinates":120},[121,122],2.24744,48.94788,{"lat":122,"lon":121},[125],{"name":126,"role":80,"phone":54,"phoneExt":54,"email":127},"Gaetan PLANTEFEVE, MD","gaetan.plantefeve@ch-argenteuil.fr",{"facility":129,"status":90,"city":130,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Hôpital Nord Franche Comté","Belfort",{"type":95,"coordinates":132},[133,134],6.85385,47.64218,{"lat":134,"lon":133},[137],{"name":138,"role":80,"phone":54,"phoneExt":54,"email":139},"Julio BADIE, MD","Julio.BADIE@hnfc.fr",{"facility":141,"status":90,"city":142,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"CH Cholet","Cholet",{"type":95,"coordinates":144},[145,146],-0.87974,47.05893,{"lat":146,"lon":145},[149],{"name":150,"role":80,"phone":54,"phoneExt":54,"email":151},"Julien DUPEYRAT, MD","julien.dupeyrat@ch-cholet.fr",{"facility":153,"status":90,"city":154,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Centre hospitalier intercommunal de Créteil","Créteil",{"type":95,"coordinates":156},[157,158],2.46569,48.79266,{"lat":158,"lon":157},[161],{"name":162,"role":80,"phone":54,"phoneExt":54,"email":82},"SCHORTGEN Frédérique, MD",{"facility":164,"status":165,"city":154,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":166,"geoPoint":168,"contacts":54},"Hôpital Henri Mondor","ACTIVE_NOT_RECRUITING",{"type":95,"coordinates":167},[157,158],{"lat":158,"lon":157},{"facility":170,"status":90,"city":171,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"CHD Dijon","Dijon",{"type":95,"coordinates":173},[174,175],5.01391,47.31344,{"lat":175,"lon":174},[178],{"name":179,"role":80,"phone":54,"phoneExt":54,"email":180},"QUENOT Jean Pierre, MD","jean-pierre.quenot@chu-dijon.fr",{"facility":182,"status":90,"city":183,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"CHU Grenoble","Grenoble",{"type":95,"coordinates":185},[186,187],5.71479,45.17869,{"lat":187,"lon":186},[190],{"name":191,"role":80,"phone":54,"phoneExt":54,"email":192},"Guillaume DUMAS, MD","GDumasgalant@chu-grenoble.fr",{"facility":194,"status":90,"city":195,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"GH Est Francilien","Jossigny",{"type":95,"coordinates":197},[198,199],2.75432,48.83765,{"lat":199,"lon":198},[202],{"name":203,"role":80,"phone":54,"phoneExt":54,"email":204},"Ly Van Phach VONG, MD","lvpvong@ghef.fr",{"facility":206,"status":90,"city":207,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"CHD Vendée","La Roche-sur-Yon",{"type":95,"coordinates":209},[210,211],-1.42757,46.66974,{"lat":211,"lon":210},[214],{"name":215,"role":80,"phone":54,"phoneExt":54,"email":216},"TOUSSAINT Aurélie, MD","aurelie.toussaint@chd-vendee.fr",{"facility":218,"status":165,"city":219,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":220,"geoPoint":224,"contacts":54},"CHU Kremlin Bicetre","Le Kremlin-Bicêtre",{"type":95,"coordinates":221},[222,223],2.36073,48.81471,{"lat":223,"lon":222},{"facility":226,"status":90,"city":227,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"CHU Le Mans","Le Mans",{"type":95,"coordinates":229},[230,231],0.20251,48.0021,{"lat":231,"lon":230},[234],{"name":235,"role":80,"phone":54,"phoneExt":54,"email":236},"Christophe GUITTON, MD","cguitton@ch-lemans.fr",{"facility":238,"status":239,"city":240,"state":54,"zip":241,"country":92,"countryCode":93,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"CH Lens","NOT_YET_RECRUITING","Lens","62300",{"type":95,"coordinates":243},[244,245],2.82791,50.43302,{"lat":245,"lon":244},[248],{"name":249,"role":80,"phone":54,"phoneExt":54,"email":54},"Camille POUTREAU, MD",{"facility":251,"status":90,"city":252,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"CH Libourne","Libourne",{"type":95,"coordinates":254},[255,256],-0.24186,44.91449,{"lat":256,"lon":255},[259],{"name":260,"role":80,"phone":54,"phoneExt":54,"email":261},"Caroline JANNIERE NARTEY, MD","caroline.janniere-nartey@ch-libourne.fr",{"facility":263,"status":239,"city":264,"state":54,"zip":265,"country":92,"countryCode":93,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Hôpital Saint Joseph Saint Luc","Lyon","69001",{"type":95,"coordinates":267},[268,269],4.84789,45.74906,{"lat":269,"lon":268},[272],{"name":273,"role":80,"phone":54,"phoneExt":54,"email":274},"Emmanuel VIVIER, MD","evivier@saintjosephsaintluc.fr",{"facility":276,"status":90,"city":264,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":277,"geoPoint":279,"contacts":280},"Hôpital de la Croix-Rousse",{"type":95,"coordinates":278},[268,269],{"lat":269,"lon":268},[281],{"name":282,"role":80,"phone":54,"phoneExt":54,"email":283},"Jean Christophe RICHARD, MD","j-christophe.richard@chu-lyon.fr",{"facility":285,"status":165,"city":286,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":287,"geoPoint":291,"contacts":54},"Hôpital Timone","Marseille",{"type":95,"coordinates":288},[289,290],5.38107,43.29695,{"lat":290,"lon":289},{"facility":293,"status":239,"city":294,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":295,"geoPoint":299,"contacts":300},"CHR Metz Hôpital de Mercy","Metz",{"type":95,"coordinates":296},[297,298],6.17269,49.11911,{"lat":298,"lon":297},[301],{"name":302,"role":80,"phone":54,"phoneExt":54,"email":303},"Guillaume LOUIS, MD","guillaume.louis@chr-metz-thionville.fr",{"facility":305,"status":90,"city":306,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"GRH Mulhouse","Mulhouse",{"type":95,"coordinates":308},[309,310],7.32866,47.75205,{"lat":310,"lon":309},[313],{"name":314,"role":80,"phone":54,"phoneExt":54,"email":315},"Anne Florence DUREAU","anne-florence.dureau@ghrmsa.fr",{"facility":317,"status":90,"city":318,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":319,"geoPoint":323,"contacts":324},"CHU Hotel Dieu","Nantes",{"type":95,"coordinates":320},[321,322],-1.55336,47.21725,{"lat":322,"lon":321},[325],{"name":326,"role":80,"phone":54,"phoneExt":54,"email":327},"LASCARROU Jean Baptiste, MD","jeanbaptiste.lascarrou@chu-nantes.fr",{"facility":329,"status":165,"city":330,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":331,"geoPoint":335,"contacts":54},"CHU Archet 1","Nice",{"type":95,"coordinates":332},[333,334],7.26608,43.70313,{"lat":334,"lon":333},{"facility":337,"status":90,"city":330,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":338,"geoPoint":340,"contacts":341},"Hôpital Pasteur",{"type":95,"coordinates":339},[333,334],{"lat":334,"lon":333},[342],{"name":343,"role":80,"phone":54,"phoneExt":54,"email":344},"Alexandre ROBERT, MD","robert.a@chu-nice.fr",{"facility":346,"status":90,"city":347,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":348,"geoPoint":352,"contacts":353},"Hopital Lariboisière - Réanimation Médicale","Paris",{"type":95,"coordinates":349},[350,351],2.3488,48.85341,{"lat":351,"lon":350},[354],{"name":355,"role":80,"phone":54,"phoneExt":54,"email":356},"DEYE Nicolas, MD","nicolas.deye@aphp.fr",{"facility":358,"status":90,"city":347,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":359,"geoPoint":361,"contacts":362},"Hôpital Lariboisière -Réanimation chirurgicale",{"type":95,"coordinates":360},[350,351],{"lat":351,"lon":350},[363],{"name":364,"role":80,"phone":54,"phoneExt":54,"email":365},"CHOUSTERMAN Benjamin, MD","benjamin.chousterman@aphp.fr",{"facility":367,"status":90,"city":368,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":369,"geoPoint":373,"contacts":374},"CHU La Milétrie Poitiers","Poitiers",{"type":95,"coordinates":370},[371,372],0.34348,46.58261,{"lat":372,"lon":371},[375],{"name":376,"role":80,"phone":54,"phoneExt":54,"email":377},"Remi COUDROY, MD","Remi.coudroy@chu-poitiers.fr",{"facility":379,"status":165,"city":380,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":381,"geoPoint":385,"contacts":54},"CHU Reims","Reims",{"type":95,"coordinates":382},[383,384],4.02853,49.26526,{"lat":384,"lon":383},{"facility":387,"status":90,"city":388,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":389,"geoPoint":393,"contacts":394},"CHU Charles Nicolle","Rouen",{"type":95,"coordinates":390},[391,392],1.09932,49.44313,{"lat":392,"lon":391},[395],{"name":396,"role":80,"phone":54,"phoneExt":54,"email":397},"Dorothée CARPENTIER, MD","dorothee.carpentier@chu-rouen.fr",{"facility":399,"status":90,"city":400,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":401,"geoPoint":405,"contacts":406},"CHU Réunion Sud","Saint-Denis",{"type":95,"coordinates":402},[403,404],2.35387,48.93564,{"lat":404,"lon":403},[407],{"name":408,"role":80,"phone":54,"phoneExt":54,"email":409},"Simon OLIVIER, MD","olivier.simon@chu-reunion.fr",{"facility":411,"status":90,"city":412,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":413,"geoPoint":417,"contacts":418},"Hôpital FOCH","Suresnes",{"type":95,"coordinates":414},[415,416],2.22929,48.87143,{"lat":416,"lon":415},[419],{"name":420,"role":80,"phone":54,"phoneExt":54,"email":421},"Jérome DEVAQUET, MD","j.devaquet@hopital-foch.org",{"facility":423,"status":90,"city":424,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":425,"geoPoint":429,"contacts":430},"CH BIGORRE SITE GESPE Tarbes","Tarbes",{"type":95,"coordinates":426},[427,428],0.07139,43.23407,{"lat":428,"lon":427},[431],{"name":432,"role":80,"phone":54,"phoneExt":54,"email":433},"Philippe PETUA, MD","ppetua@ch-tarbes-vic.fr",{"facility":435,"status":90,"city":436,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":437,"geoPoint":441,"contacts":442},"CHBA Vannes-Auray","Vannes",{"type":95,"coordinates":438},[439,440],-2.76205,47.65688,{"lat":440,"lon":439},[443],{"name":444,"role":80,"phone":54,"phoneExt":54,"email":445},"Agathe Delbove, MD","agathe.delbove@ch-bretagne-atlantique.fr",{"facility":447,"status":90,"city":448,"state":54,"zip":54,"country":92,"countryCode":93,"cosmosGeoPoint":449,"geoPoint":453,"contacts":454},"Centre Hospitalier Mignot","Versailles",{"type":95,"coordinates":450},[451,452],2.13424,48.80359,{"lat":452,"lon":451},[455],{"name":456,"role":80,"phone":54,"phoneExt":54,"email":457},"LEGRIEL Stéphane, MD","slegriel@ght78sud.fr",{"type":459,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100400426","fever-control-using-external-cooling-in-mechanically-ventilated-patients-with-septic-shock-100400426",false,"NCT04494074","Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock","Intérêt du Traitement de la fièvre Par Refroidissement Externe Pour la Survie Des Patients ventilés en Choc Septique","Inclusion Criteria:\n\n* Documented or suspected infection either communautary or hospital acquired\n* Septic shock defined by the need for vasopressor and lactate\\>2 mmol\u002Fl despite adequate fluid resuscitation (sepsis-3 definition)\n* Patients under invasive mechanical ventilation\n* Body core temperature\\>38.3°C\n* Intravenous sedation or opioids\n* Ongoing antimicrobial treatment and\u002For intervention for infection source control\n* Attending physician confirms clinical equipoise without substantial risk if the patient participates in the trial\n* Informed consent of next of kin\u002Fother designated person before inclusion or procedure for inclusion in emergency situation\n\nExclusion Criteria:\n\n* Cardiac arrest within previous 7 days\n* Acute brain injury within previous 7 days\n* Extensive burns or epidermal necrolysis\n* \\\u003C18 years old\n* Body core temperature \\>41°C\n* Under legal guardianship\n* No affiliation with the French health-care system\n* Pregnancy\n* Participation in another interventional study with mortality as the primary endpoint\n* An investigator's decision not to resuscitate\n* Patient already recruited in the trial","ALL","18 Years",{"count":470,"type":471},820,"ESTIMATED","INTERVENTIONAL",[474],"NA","The best strategy for managing fever in patients with septic shock remains unknown. In a pilot study, the investigators showed that fever control at normothermia allowed a better control of shock and evolution of organ failures. In this second trial the investigators will conduct a multicentre, open-label, randomized controlled, superiority trial in which two strategies will be compared:\n\n1. Respect of fever\n2. Fever control at normothermia using external cooling The primary end point will be d-60 mortality.",[477],"Septic Shock",[479,480,481],"External cooling,","Fever","ARDS","2026-09-17",{"date":484,"type":485},"2026-09-21","ACTUAL",{"date":487,"type":485},"2022-10-01",{"date":489,"type":471},"2028-12-01",{"name":5,"class":6},33]