[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598171":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":33,"responsibleParty":276,"collaborators":10,"id":280,"slug":10,"hasResults":281,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":281,"sex":287,"minAge":288,"maxAge":10,"enrollmentInfo":289,"targetDuration":10,"studyType":292,"phases":10,"briefSummary":293,"conditions":294,"keywords":300,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":320},{"fullName":5,"class":6},"Argentinian Intensive Care Society","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Obstetric patients= pregnant and postpartum (\u003C 3 days) patients requiring ICU admission",null,"All pregnant and postpartum (\\\u003C 3 days) patients requiring ICU admission will be followed during their ICU-LOS. The predictive validity for ICU mortality of an adjusted to obstetric patients Sequential Organ Failure Assessment (SOFA-OBS) score will be compared to the predictive validity of a non-modified Sequential Organ Failure Assessment (SOFA) score.",[13],"Other: Organ dysfunction score adjusted to obstetric patients (SOFA-OBS)",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Organ dysfunction score adjusted to obstetric patients (SOFA-OBS)","The obstetric SOFA (SOFA-OBS) adjusts renal and cardiovascular variables to physiological changes of pregnancy. Moreover, it simplifies respiratory evaluation, in terms of replacing arterial blood gases (ABG) for peripheral oxygen saturation\u002Ffraction of inspired oxygen (spO2\u002FFiO2), when ABGs were not available. Variables unchanged during pregnancy (neurologic, hepatic and platelets), won't be modified.",[9],[20],{"name":21,"affiliation":22,"role":23},"Daniela N. Vasquez, MD","Sanatorio Anchorena Recoleta","PRINCIPAL_INVESTIGATOR",[25,29],{"name":21,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+5492215041762","danielavasquez73@gmail.com",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Andrea V. Das Neves, MD","+5492215792555","av.dasneves@gmail.com",[34,53,67,76,90,104,118,129,143,158,174,190,205,212,220,228,244,260],{"facility":35,"status":36,"city":37,"state":38,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Sanatorio Itoiz","RECRUITING","Avellaneda","Buenos Aires","Argentina","AR",{"type":42,"coordinates":43},"Point",[44,45],-59.65834,-29.11761,{"lat":45,"lon":44},[48,52],{"name":49,"role":26,"phone":50,"phoneExt":10,"email":51},"Cristina Palacio, MD","+5491169708937","crismp65@hotmail.com",{"name":49,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":54,"status":36,"city":55,"state":38,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Hospital Cuenca Alta Néstor Kirchner","Canuelas",{"type":42,"coordinates":57},[58,59],-58.76205,-35.05379,{"lat":59,"lon":58},[62,66],{"name":63,"role":26,"phone":64,"phoneExt":10,"email":65},"Verónica Iglesias, MD","541152734700","veronica.s.iglesias@gmail.com",{"name":63,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":22,"status":36,"city":68,"state":38,"zip":69,"country":39,"countryCode":40,"cosmosGeoPoint":10,"geoPoint":10,"contacts":70},"City of Buenos Aires","1894",[71,73,74],{"name":21,"role":26,"phone":72,"phoneExt":10,"email":28},"0221155041762",{"name":10,"role":26,"phone":10,"phoneExt":10,"email":28},{"name":75,"role":23,"phone":10,"phoneExt":10,"email":10},"Daniela N. Vasquez, Medical Doctor",{"facility":77,"status":36,"city":78,"state":38,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Hospital Simplemente Evita","González Catán",{"type":42,"coordinates":80},[81,82],-58.64802,-34.76918,{"lat":82,"lon":81},[85,89],{"name":86,"role":26,"phone":87,"phoneExt":10,"email":88},"Eva Rodríguez, MD","+5491162470901","eva83rc@gmail.com",{"name":86,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":91,"status":36,"city":92,"state":38,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Hospital Mi Pueblo Florencio Varela","San Juan Bautista",{"type":42,"coordinates":94},[95,96],-58.27623,-34.80896,{"lat":96,"lon":95},[99,103],{"name":100,"role":26,"phone":101,"phoneExt":10,"email":102},"Pedro D Macharé, MD","+5491163662704","macharep@yahoo.com.ar",{"name":100,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":105,"status":36,"city":106,"state":38,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Hospital Thompson","San Martín",{"type":42,"coordinates":108},[109,110],-57.75317,-35.02575,{"lat":110,"lon":109},[113,117],{"name":114,"role":26,"phone":115,"phoneExt":10,"email":116},"Lorena Franconieri, MD","+5491156359974","lorena_franconieri@hotmail.com",{"name":114,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":119,"status":36,"city":106,"state":38,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":120,"geoPoint":122,"contacts":123},"Sanatorio Anchorena San Martín",{"type":42,"coordinates":121},[109,110],{"lat":110,"lon":109},[124,128],{"name":125,"role":26,"phone":10,"phoneExt":126,"email":127},"Sebastián Torres, MD","+5491130453650","sstorres01@gmail.com",{"name":125,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":130,"status":36,"city":131,"state":38,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Hospital Materno Infantil Dr. F Escardó","Tigre",{"type":42,"coordinates":133},[134,135],-58.57962,-34.42603,{"lat":135,"lon":134},[138,142],{"name":139,"role":26,"phone":10,"phoneExt":140,"email":141},"Diego Lafosse, MD","+5491162799450","diegolafosse03@gmail.com",{"name":139,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":144,"status":36,"city":145,"state":146,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Hospital de la Madre y el Niño","La Rioja","La Rioja Province",{"type":42,"coordinates":148},[149,150],-66.85637,-29.41328,{"lat":150,"lon":149},[153,157],{"name":154,"role":26,"phone":155,"phoneExt":10,"email":156},"Paula A Juárez, MD","+5493804531582","dra.paulajuarez@gmail.com",{"name":154,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":159,"status":160,"city":161,"state":162,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Hospital Regional Diego Paroissien","NOT_YET_RECRUITING","Mendoza","Mendoza Province",{"type":42,"coordinates":164},[165,166],-68.84582,-32.88946,{"lat":166,"lon":165},[169,173],{"name":170,"role":26,"phone":171,"phoneExt":10,"email":172},"Viviana V Chapier, MD","+5492613602148","vchapier@gmail.com",{"name":170,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":175,"status":160,"city":176,"state":177,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Maternidad Provincial Teresita Baigorria","San Luis","San Luis Province",{"type":42,"coordinates":179},[180,181],-66.32467,-33.2914,{"lat":181,"lon":180},[184,188],{"name":185,"role":26,"phone":186,"phoneExt":10,"email":187},"Erika Barrozo, MD","+5491156354032","erikabarrozo@yahoo.com.ar",{"name":189,"role":23,"phone":10,"phoneExt":10,"email":10},"Erika Barrozo",{"facility":191,"status":160,"city":192,"state":193,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Hospital Regional Ramón Carrillo","Santiago del Estero","Santiago del Estero Province",{"type":42,"coordinates":195},[196,197],-64.26285,-27.80047,{"lat":197,"lon":196},[200,204],{"name":201,"role":26,"phone":202,"phoneExt":10,"email":203},"Roberto Giannoni, MD","+5491140998912","robergiannoni@gmail.com",{"name":201,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":206,"status":160,"city":68,"state":10,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":10,"geoPoint":10,"contacts":207},"Sanatorio Antártida",[208],{"name":209,"role":26,"phone":210,"phoneExt":10,"email":211},"Ernesto Porjolovsky, MD","+5491161898932","ernestoporjolovsky@gmail.com",{"facility":213,"status":160,"city":68,"state":10,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":10,"geoPoint":10,"contacts":214},"Sanatorio Finochietto",[215,219],{"name":216,"role":26,"phone":217,"phoneExt":10,"email":218},"Mariana Kirschbaum, MD","+541158259669","marikirschbaum@gmail.com",{"name":216,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":221,"status":36,"city":68,"state":10,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":10,"geoPoint":10,"contacts":222},"Sanatorio Guemes",[223,227],{"name":224,"role":26,"phone":10,"phoneExt":225,"email":226},"Ignacio Romero, MD","+5491130454526","dr.ignacio.romero@gmail.com",{"name":224,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":229,"status":36,"city":230,"state":10,"zip":10,"country":231,"countryCode":232,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Hospital Gineco Obstétrico Isidro Ayora","Quito","Ecuador","EC",{"type":42,"coordinates":234},[235,236],-78.52495,-0.22985,{"lat":236,"lon":235},[239,243],{"name":240,"role":26,"phone":241,"phoneExt":10,"email":242},"Liliana Torres, MD","+593979011019","dra.lili.torres@gmail.com",{"name":240,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":245,"status":160,"city":246,"state":10,"zip":10,"country":247,"countryCode":248,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Hospital Materno Infantil 1 de mayo","San Salvador","El Salvador","SV",{"type":42,"coordinates":250},[251,252],-89.18718,13.68935,{"lat":252,"lon":251},[255,259],{"name":256,"role":26,"phone":257,"phoneExt":10,"email":258},"Eduardo Turcios, MD","+50377304450","dreturcios@yahoo.com",{"name":256,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":261,"status":160,"city":262,"state":10,"zip":10,"country":263,"countryCode":264,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"Hospital de Clínicas Dr. Manuel Quintela","Montevideo","Uruguay","UY",{"type":42,"coordinates":266},[267,268],-56.18816,-34.90328,{"lat":268,"lon":267},[271,275],{"name":272,"role":26,"phone":273,"phoneExt":10,"email":274},"Lucía Urroz, MD","+59899727017","lucia.uvl@gmail.com",{"name":272,"role":23,"phone":10,"phoneExt":10,"email":10},{"type":277,"investigatorFullName":278,"investigatorTitle":279,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Daniela Vasquez","Medical Doctor, Researcher","100598171",false,"NCT07068022","Organ Dysfunction Score for Obstetric Patients","Development and Validation of an Obstetric Organ Dysfunction Score to Predict Mortality in Intensive Care Unit: A Multicenter, Prospective, Cohort Study","SOFA-OBS","Inclusion Criteria:\n\nAll of the following=\n\n* Pregnant (at any gestational age) or post-partum patients (at ≤3 days postpartum)\n* ≥ 18 years old\n* Requiring admission to ICU for any reason\n* Staying in the ICU for ≥ 24h\n* Giving her consent to participate. Patients will be recruited consecutively until reaching the sample size.\n\nExclusion Criteria:\n\nAny of the following=\n\n* Patients \\\u003C18 years old\n* Non-pregnant patients\n* ≥ 4 days postpartum\n* Patients or surrogates not giving consent to participate\n* ICU-LOS \\\u003C 24 h","FEMALE","18 Years",{"count":290,"type":291},130,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to develop and evaluate an organ dysfunction score adapted to pregnancy and early puerperium (SOFA-OBS) that also incorporates a non-invasive tool to evaluate respiratory function (pulse oximeter).\n\nThe main question it aims to answer is: Does an organ dysfunction score adapted to pregnant and postpartum patients have a higher capacity to predict mortality than a non-adjusted organ dysfunction score? Participants: Patients requiring ICU (Intensive Care Units) admission, who are either pregnant or postpartum (up to 3 days after giving birth). The investigators aimed to include 130 participants.\n\nThe investigators will only collect participants' data and laboratory results that ICU doctor usually need for clinical practice. No additional interventions are required. Moreover, the investigators will evaluate if measuring participants' oxygenation through a non-invasive tool (pulse oximeter) is equally effective as measuring oxygenation by an arterial puncture.\n\nBackground: When managing severely ill patients in ICU, the investigators often use what it is called scores. Scores refer to a numerical value assigned to a patient's condition, which often predict outcome. The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assess severity of organ dysfunction (in liver, kidney, blood pressure, respiratory, neurologic and platelets). It also identifies patients with severe infections (sepsis) and patients with bad outcomes.\n\nPatients undergoing pregnancy or early postpartum develop physiological changes, such us a decrease in creatinine (a laboratory test measuring kidney function) and a decrease in blood pressure during the second trimester. These changes are not considered by the SOFA score. Actually, there is not an organ dysfunction score adapted to pregnant\u002Fpostpartum patients to be used in the ICU. Moreover, a blood sample taken by arterial puncture is required to evaluate respiratory function by the SOFA score, which is a painful procedure. Instead, the investigators could evaluate respiratory function using a pulse oximeter, which measures peripheral oxygen saturation without needing an arterial puncture.\n\nPotential benefits: A SOFA-OBS would hopefully become a more precise tool than general SOFA to evaluate organ dysfunction and to predict outcome among these patients. It would also help to detect sepsis earlier and treat it promptly, which might help reducing its mortality.",[295,296,297,298,299],"Pregnancy","Postpartum","Organ Dysfunction","Critical Care, Intensive Care","Sepsis",[301,295,296,302,303,304,305,306,307,308,299,309,310],"Sequential Organ Failure Assessment score","Critical care","Intensive Care Unit","Creatinine","Peripheral oxygen saturation","Hypotension","Maternal mortality","Mortality","Septic shock","Multicenter study","2026-04-22",{"date":313,"type":314},"2026-04-28","ACTUAL",{"date":316,"type":314},"2025-10-06",{"date":318,"type":291},"2027-02-28",{"name":278,"class":6},18]