[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503516":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":60,"collaborators":31,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":31,"enrollmentInfo":72,"targetDuration":31,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":45,"whyStopped":31,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Tunis University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early NE","ACTIVE_COMPARATOR","The early NE arm will receive low-dose NE as soon as hypotension secondary to sepsis is observed in addition to a classic therapeutic regimen that complies with the guidelines of the 2021 Surviving Sepsis Compaign. Sepsis is defined according to the sepsis 3 consensus by a sepsis related organ failure assessment (SrOFA) score greater than 2 following an infection (documented or suspected)",[13],"Drug: Norepinephrine Bitartrate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","The placebo arm will receive only the classic therapeutic regimen that complies with the guidelines of the 2021 Surviving Sepsis Compaign.",[19],"Other: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Norepinephrine Bitartrate","The NE will be prepared as follows: 4 mg mixed with 250 ml of 5% glucose resulting in a final norepinephrine concentration of 0.016 mg\u002Fml. For the control group placebo: 250 ml of 5% glucose will be prepared.\n\nBoth drugs will be infused via a peripheral line or a venous catheter. The intravenous infusion rate varies from 8 to 15 ml\u002Fhour, adjusted according to body weight to obtain norepinephrine at 0.05 microgram\u002Fkg\u002Fmin (ie 0.128 to 0.24 mg per hour) in continuous infusion.",[9],[27],"Norepinephrine 0,016 mg\u002Fml",{"type":6,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"For the control group placebo: 250 ml of 5% glucose will be prepared and will be infused via a peripheral line or a venous catheter. The intravenous infusion rate varies from 8 to 15 ml\u002Fhour.",[15],null,[33],{"name":34,"affiliation":35,"role":36},"Ahlem Trifi","Hopital La Rabta","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":31,"email":41},"CONTACT","98692699","trifiahlem2@gmail.com",[43],{"facility":44,"status":45,"city":46,"state":31,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"intensive care unit of the University Hospital Center La Rabta","RECRUITING","Tunis","1007","Tunisia","TN",{"type":51,"coordinates":52},"Point",[53,54],10.16579,36.81897,{"lat":54,"lon":53},[57],{"name":34,"role":39,"phone":58,"phoneExt":31,"email":59},"+21698692699","ahlem.ahurabta@gmail.com",{"type":36,"investigatorFullName":34,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Associate Professor","100503516","phase-4-early-administration-of-norepinephrine-in-sepsis-100503516",false,"NCT05836272","Early Administration of Norepinephrine in Sepsis","Early Administration of Norepinephrine in Sepsis (Tunisian Multicenter Randomized Trial)","EA-NE-TUN","Inclusion Criteria:\n\n* Age 18 or older.\n* The patient or his\u002Fher legal representative has given informed consent in writing.\n* Diagnosis of sepsis according to the definitions updated by the consensus of sepsis 3.\n* Mean arterial pressure \\\u003C 65 mmHg\n\nExclusion Criteria:\n\n* Diagnosis of septic shock prior to randomization (where NA requirements exceed those of the trial protocol)\n* Pregnancy,\n* Need for immediate surgery,\n* Neoplasia at an advanced stage\n* Circumstances where water restriction is the rule:\n* Acute pulmonary edema\n* Acute coronary syndrome,","ALL","18 Years",{"count":73,"type":74},200,"ESTIMATED","INTERVENTIONAL",[77],"PHASE4","The management of septic states includes, in addition to the specific treatment (antimicrobials and eradication of the source), a restoration of the hemodynamic disorders and assistance of the failing organs. In general, the restoration of hemodynamic disorders begins first with volume expansion, followed by the use of Noepinephrine (NE) when the target mean arterial pressure (MAP) is not reached after optimizing the intravascular volume. Recently, several studies have supported the interest of early NE on MAP, cardiac output and mortality. It is therefore tempting to restrict fluid administration even in the initial phase of hemodynamic management of severe sepsis by starting NE earlier.",[80],"Sepsis, Severe",[82,83,84,85,86],"sepsis","septic shock","Norepinephrine","volume expansion","mortality","2024-12-02",{"date":89,"type":90},"2024-12-04","ACTUAL",{"date":92,"type":90},"2023-08-01",{"date":94,"type":74},"2025-08",{"name":5,"class":6},1]