protocolSection identificationModule nctId: NCT06265259, orgStudyIdInfo id: 31-05-2023/25481, briefTitle: Efficacy of the Use of Vasopressin as a Primary Vasoconstrictor in Critically Ill Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Thessaly, class: OTHER, descriptionModule briefSummary: Current guidelines recommend the inititaion of noradrenaline and if shock is refractory, then vasopressin should be administered. Data indicate that the earlier use of vasopressin may improve survival. Two large randomized controlled trial failed to prove a survival benefit from the early use of vasopressin. The present study will investigate the effect of an early initiation protocol of vasopressin (as the first vasoconstrictor drug) on the degree of multiorgan failure improvement and also on the course of sepsis (if in septic patients) versus early initiation of noradrenaline as first vasoconstrictor drug in hemodynamically unstable patients., conditionsModule conditions: Circulatory Shock, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 145, type: ESTIMATED, armsInterventionsModule interventions name: Initiation of vasopressine as a first vasoconstrictive drug, interventions name: Initiation of noradrenaline as a first vasoconstrictive drug, outcomesModule primaryOutcomes measure: Multiorgan failure improvement assessment, secondaryOutcomes measure: Sepsis course, secondaryOutcomes measure: Sepsis course, secondaryOutcomes measure: Sepsis course, secondaryOutcomes measure: Duration of administration of vasoconstrictors, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: Cardiac enzymes, secondaryOutcomes measure: Cardiac enzymes, secondaryOutcomes measure: renal function, secondaryOutcomes measure: renal function, secondaryOutcomes measure: renal function, secondaryOutcomes measure: Mechanical ventilation duration, secondaryOutcomes measure: length of ICU stay, secondaryOutcomes measure: 28 day mortality, secondaryOutcomes measure: ICU mortality, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General University Hospital of Larissa, Intensive Care Unit, status: RECRUITING, city: Larissa, state: Thessaly, zip: 41110, country: Greece, contacts name: Vasiliki Tsolaki, role: CONTACT, phone: 00306972804419, email: vasotsolaki@yahoo.com, contacts name: Epaminondas Zakynthinos, Prof, role: CONTACT, phone: 00302413501280, email: ezakynth@yahoo.com, contacts name: Vasiliki TSOLAKI, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Asimina Valsamaki, MD, Msc, role: SUB_INVESTIGATOR, contacts name: Epaminondas Zakynthinos, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.63689, lon: 22.41761, hasResults: False