[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488062":3},{"organization":4,"armGroups":7,"interventions":51,"overallOfficials":78,"centralContacts":83,"locations":91,"responsibleParty":108,"collaborators":57,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":57,"enrollmentInfo":122,"targetDuration":57,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":57,"overallStatus":94,"whyStopped":57,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14,20,25,30,35,41,46],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexamethasone","EXPERIMENTAL","The dexamethasone kit will contain 20 mg of dexamethasonphosfat (Dexavit®,Vital Pharma Nordic), 4mg\u002FmL, i.e. 5 mL, which corresponds to 16.67 mg of dexamethasone. Dexamethasone will be administered as an intravenous bolus infusion over 2 minutes after induction of anaesthesia.",[13],"Drug: Dexamethasone phosphate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (for Dexamethasone)","PLACEBO_COMPARATOR","The placebo kit will contain 5 mL of isotonic (0.9%) normal saline. Placebo will be administered as an intravenous bolus infusion over 2 minutes after induction of anaesthesia.",[19],"Drug: Isotonic sodium chloride (0.9%)",{"label":21,"type":10,"description":22,"interventionNames":23},"Olanzapine","The olanzapine kit will consist of two capsules each containing two 2.5 mg tablets of olanzapine (Olanzapine Stada®, STADA Nordic); i.e. total dose 10mg. The capsules will be delivered to the patient with instruction to take the capsule orally along with other standardized pre-procedure medicine. Patient intake will be recorded.",[24],"Drug: Olanzapine 10 MG",{"label":26,"type":16,"description":27,"interventionNames":28},"Placebo (for Olanzapine)","The placebo kit will consist of two placebo capsules identical to the capsules containing the olanzapine tablet. The capsules will be delivered to the patient with instruction to take the capsule orally along with other standardized pre-procedure medicine. Patient intake will be recorded.",[29],"Drug: Placebo capsule",{"label":31,"type":10,"description":32,"interventionNames":33},"Flow-targeted hemodynamic management","In the 'flow group', an arterial oxygen delivery (DO2) above 274 mL\u002Fmin\u002Fm2 BSA AND a central venous oxygen saturation (ScvO2) above 70% will be targeted. CPB pump flow will be initiated at a flow rate of 2.4 L\u002Fmin\u002Fm2. If DO2 or ScvO2 are below target, CPB pump flow will be gradually increased until targets are reached up to a maximum CPB pump flow of 3.2 L\u002Fmin\u002Fm2. If DO2 or ScvO2 are below targets despite a maximum CPB pump flow, PaO2 will be gradually increased from an initial target of 15-20 kPa to a maximum of 40 kPa. A haematocrit level equal to or above 21% will be targeted, however, if DO2 or ScvO2 are below target despite a CPB pump flow of 3.2 L\u002Fmin\u002Fm2, the haematocrit target level will be increased to equal to or above 25%. A MAP down to 35 mmHg will be tolerated throughout. The MAP target will be achieved by administration of boluses of phenylephrine up to a total of 2.0 mg, which can be followed by a continuous infusion of norepinephrine up to 0.6 μg per kg per min.",[34],"Procedure: Flow-targeted hemodynamic management",{"label":36,"type":37,"description":38,"interventionNames":39},"Pressure-targeted hemodynamic management","ACTIVE_COMPARATOR","In the 'pressure group' a MAP between 70 to 80 mmHg will be targeted. The assigned MAP target will be achieved by administration of boluses of phenylephrine up to a total of 2.0 mg, which can be followed by a continuous infusion of norepinephrine up to 0.6 μg per kg per min. CPB pump flow will be fixed at a flow rate of 2.4 L per minute per square meter body surface area. A haematocrit level equal to or above 21% will be targeted throughout. A PaO2 of 15-20 kPa will be targeted throughout.",[40],"Procedure: Pressure-targeted hemodynamic management",{"label":42,"type":10,"description":43,"interventionNames":44},"Low tidal-volume ventilation","During initiation of CPB, the 'ventilation' group will receive a tidal volume at 3ml\u002Fkg and a set PEEP of 3 cm H2O. The respiratory frequency (RF) will be set at 10, and the inspiratory: expiratory (I:E) ratio will be set to 5:1. Peak pressures (Pmax) will be limited to \\\u003C 25 cm H2O. FiO2 will be set at 50%. The ventilation strategy will be maintained during CPB.\n\nAny recruitment manoeuvres will be initiated solely at the discretion of the attending anaesthesiologist, and only if the patient's oxygen saturation drops below 88%. All recruitment manoeuvres will be completed by increasing the inspiratory pressure to 20 cmH2O for 10 seconds. The manoeuvre will be repeated three times.",[45],"Procedure: Low tidal-volume ventilation",{"label":47,"type":37,"description":48,"interventionNames":49},"No ventilation","The 'no-ventilation' group will receive no ventilation or PEEP. The ventilation strategy will be maintained during CPB.\n\nAny recruitment manoeuvres will be initiated solely at the discretion of the attending anaesthesiologist, and only if the patient's oxygen saturation drops below 88%. All recruitment manoeuvres will be completed by increasing the inspiratory pressure to 20 cmH2O for 10 seconds. The manoeuvre will be repeated three times.",[50],"Procedure: No ventilation",[52,58,61,65,69,72,74,76],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"DRUG","Dexamethasone phosphate","See description of arms",[9],null,{"type":53,"name":59,"description":55,"armGroupLabels":60,"otherNames":57},"Isotonic sodium chloride (0.9%)",[15],{"type":53,"name":62,"description":63,"armGroupLabels":64,"otherNames":57},"Olanzapine 10 MG","Olanzapine tablet pre-hidden in capsule identical to the placebo tablet",[21],{"type":53,"name":66,"description":67,"armGroupLabels":68,"otherNames":57},"Placebo capsule","capsule identical to capsule containing olanzapine",[26],{"type":70,"name":31,"description":55,"armGroupLabels":71,"otherNames":57},"PROCEDURE",[31],{"type":70,"name":36,"description":55,"armGroupLabels":73,"otherNames":57},[36],{"type":70,"name":42,"description":55,"armGroupLabels":75,"otherNames":57},[42],{"type":70,"name":47,"description":55,"armGroupLabels":77,"otherNames":57},[47],[79],{"name":80,"affiliation":81,"role":82},"Christian Hassager, MD, DMSc","Sponsor GmbH","STUDY_CHAIR",[84,89],{"name":85,"role":86,"phone":87,"phoneExt":57,"email":88},"Sebastian Wiberg, MD, PhD","CONTACT","+45 35 45 17 10","sebastian.christoph.wiberg@regionh.dk",{"name":80,"role":86,"phone":57,"phoneExt":57,"email":90},"christian.hassager@regionh.dk",[92],{"facility":93,"status":94,"city":95,"state":57,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"The Heart Centre, Rigshospitalet","RECRUITING","Copenhagen","2200","Denmark","DK",{"type":100,"coordinates":101},"Point",[102,103],12.56553,55.67594,{"lat":103,"lon":102},[106,107],{"name":80,"role":86,"phone":57,"phoneExt":57,"email":90},{"name":85,"role":86,"phone":57,"phoneExt":57,"email":88},{"type":109,"investigatorFullName":110,"investigatorTitle":111,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"PRINCIPAL_INVESTIGATOR","Sebastian Wiberg","Principal Investigator, MD, PhD","100488062","dexamethasone-olanzapine-hemodynamics-and-ventilation-in-cardiac-surgery-100488062",false,"NCT05635227","Dexamethasone, Olanzapine, Hemodynamics, and Ventilation in Cardiac Surgery","Dexamethasone, Olanzapine, Flow-targeted Versus Pressure-targeted Hemodynamic Management, and Low Tidal Volume Ventilation in Patients Undergoing On-pump Cardiac Surgery - a Multifactorial Design Randomized Trial","GLORIOUS-II","Inclusion Criteria:\n\n1. Adult, i.e., above 18 years of age\n2. Scheduled for CABG and\u002For AVR, irrespective of other concomitant valve surgery.\n\nExclusion Criteria:\n\n1. Acute surgery (i.e. off hours surgery)\n2. Pregnancy or currently breastfeeding. Pregnancy in all fertile women will be ruled out by pregnancy testing prior to randomization.\n3. Known endocarditis at time of screening\n4. Previous participation in the trial\n5. Active infection, including bacterial, viral, and\u002For fungal infection\n6. Known hepatic cirrhosis\n7. Known severe thrombocytopenia with thrombocyte levels \\\u003C 50 x 109\u002FL\n8. Known severe neutropenia with neutrocyte levels \\\u003C 2 x 109\u002FL\n9. On the waiting list for a heart transplant\n10. Recipient of any major organ transplant\n11. Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism\n12. Having received cytotoxic\u002Fcytostatic chemotherapy or radiation therapy for treatment of malignancy within the last 6 months.\n13. Clinical evidence of current malignancy except for basal or localized squamous cell carcinoma, cervical intraepithelial neoplasia or stable prostate cancer.\n14. Known narrow-angle glaucoma\n15. Known phenylketonuria\n16. Type I diabetes\n17. Known long QT syndrome\n18. Known allergy for any of the included study drugs\n19. Any condition, where participation in the study, in the investigator's opinion could put the subject at risk, confound the study results or interfere significantly with participation in the study\n\nPatients with extracardiac arteriopathy (assessed as part of the pre-operative EuroSCORE) will be excluded from the intervention 'flow-targeted vs. pressure-targeted hemodynamic management during CPB'.","ALL","18 Years",{"count":123,"type":124},1200,"ESTIMATED","INTERVENTIONAL",[127],"NA","Open heart surgery, including coronary artery bypass grafting (CABG) and\u002For aortic valve replacement (AVR) is associated with a significant risk of mortality.\n\nThis study is a randomized clinical trial with the purpose of investigating four different interventions on the primary endpoint 'days alive and outside of hospital within 90 days'.\n\nThe interventions are:\n\n* Dexamethasone vs. placebo administered after induction of anesthesia.\n* Olanzapine vs. placebo administered prior to anesthesia.\n* A blood-flow targeted vs. a blod-pressure targeted hemodynamic strategy while the patient is on cardio-pulmonary bypass (CPB)\n* Low-tidal volume ventilation vs. no ventilation of the lungs while the patient is on CPB",[130,131],"Coronary Artery Disease","Aortic Valve Disease","2025-04-01",{"date":134,"type":135},"2025-04-04","ACTUAL",{"date":137,"type":135},"2022-11-10",{"date":139,"type":124},"2028-02",{"name":5,"class":6},1]