[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584125":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":124,"collaborators":127,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":133,"sex":139,"minAge":140,"maxAge":25,"enrollmentInfo":141,"targetDuration":25,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Jagiellonian University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","ACTIVE_COMPARATOR","In the intervention group, a standardized noradrenaline infusion at a concentration of 10 µg\u002FmL will be initiated 15 to 60 seconds before induction of anaesthesia. The infusion will be titrated and maintained during surgery and postoperatively for up to 4 hours, with a minimum duration of 2 hours, until haemodynamic stability is achieved. Haemodynamic stability is defined as stable blood pressure requiring minimal noradrenaline support of 0.01 µg\u002Fkg\u002Fmin or less for at least 1 hour. We will mandate avoidance of mean arterial pressure decreasing below 60 to 70 mm Hg. Once haemodynamic stability is achieved during the postoperative observation period, noradrenaline infusion may be discontinued. Safety criteria for discontinuation include systolic blood pressure above 180 mm Hg, in which case the infusion will be stopped. If systolic blood pressure is between 140 and 170 mm Hg, dose reduction or continuation at a very low noradrenaline infusion of 0.005 µg\u002Fkg\u002Fmin, approximately 1 mL per h",[13],"Drug: noradrenaline infusion for management blood pressure",{"label":15,"type":10,"description":16,"interventionNames":17},"Control group","Standard blood pressure management reactive to blood pressure values. According to the 2022 ESA\u002FESC guidelines, patients in the control group will be treated to avoid a mean arterial pressure below 60 to 70 mm Hg. Ephedrine boluses (5 mg per bolus, up to a total intravenous dose of 25 mg) are recommended as first line treatment for hypotension. If hypotension persists, peripheral noradrenaline may be administered. Due to variability in clinical practice regarding the choice and timing of vasopressors and fluid therapy during and after surgery, further protocolization of hypotension management will not be mandated in order to enhance feasibility and generalizability of the trial.",[18],"Combination Product: standard blood pressure management",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","noradrenaline infusion for management blood pressure","A single concentration of noradrenaline (10 μg\u002Fml) will be initiated 15-60 seconds prior to the induction of anaesthesia, then titrated and maintained until 4 hours after surgery to meet pre-specified mean arterial pressure (MAP) targets. The drug infusion will be started at a dose of 0.01 μg\u002Fkg\u002Fmin and will be titrated to a maximum of 0.1 μg\u002Fkg\u002Fmin. Anaesthesiologists will be advised to use the lowest possible dose of noradrenaline. Avoidance of MAP decreases of \\>20% from baseline values or \\\u003C60-70 mm Hg will be required in both groups. Individual baseline MAP value will be defined as resting blood pressure obtained in at least two measurements at the surgery ward on the day before surgery. Noradrenaline will be administered peripherally in all patients who do not have a central venous catheter in place.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"COMBINATION_PRODUCT","standard blood pressure management","Patients in the control group will receive standard blood pressure management reactive to blood pressure values. In the light of the current ESA\u002FESC 2022 guidelines, all patients in the control group will be treated to avoid MAP \\\u003C60-70 mm Hg. Ephedrine boluses (5 mg each, up to 25 mg total intravenous dose) will be recommended as a first-line hypotension treatment. Subsequent treatment will involve administering peripheral noradrenaline. Notwithstanding, there is a variation in clinical practice regarding the choice and timing of vasopressors and fluids to be administered during and after surgery, therefore, hypotension treatment will not be further protocolized to increase the feasibility and generalizability of the trial.",[15],[32],{"name":33,"affiliation":34,"role":35},"Wojciech Szczeklik, MD, PhD","Centre for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Bożena Seczyńska, PhD","CONTACT","(+48) 124332847","bozena.seczynska@uj.edu.pl",{"name":43,"role":39,"phone":44,"phoneExt":25,"email":45},"Zbigniew Putowski, MD, PhD","(+48) 126308267","zbigniew.putowski@uj.edu.pl",[47,67,84,94,109],{"facility":48,"status":49,"city":50,"state":25,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibińskiego Śląski Uniwersytet Medyczny","RECRUITING","Katowice","40-752","Poland","PL",{"type":55,"coordinates":56},"Point",[57,58],19.02173,50.2597,{"lat":58,"lon":57},[61,65],{"name":62,"role":39,"phone":63,"phoneExt":25,"email":64},"Anna Szczepańska, MD, PhD","(+48) 7894111","badaniakliniczne@uck.katowice.pl",{"name":62,"role":66,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":68,"status":49,"city":69,"state":25,"zip":70,"country":52,"countryCode":53,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"5 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie","Krakow","30-901",{"type":55,"coordinates":72},[73,74],19.93658,50.06143,{"lat":74,"lon":73},[77,80,81,82],{"name":33,"role":39,"phone":78,"phoneExt":25,"email":79},"(+48) 12 63 08 267","sekretariat@5wszk.com.pl",{"name":43,"role":39,"phone":78,"phoneExt":25,"email":79},{"name":33,"role":66,"phone":25,"phoneExt":25,"email":25},{"name":43,"role":83,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"facility":85,"status":86,"city":87,"state":25,"zip":88,"country":52,"countryCode":53,"cosmosGeoPoint":89,"geoPoint":93,"contacts":25},"Wojewódzki Szpital Specjalistyczny w Olsztynie","ACTIVE_NOT_RECRUITING","Olsztyn","10-561",{"type":55,"coordinates":90},[91,92],20.49272,53.78376,{"lat":92,"lon":91},{"facility":95,"status":49,"city":96,"state":25,"zip":97,"country":52,"countryCode":53,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Uniwersytecki Szpital Kliniczny w Opolu","Opole","45-401",{"type":55,"coordinates":99},[100,101],17.92604,50.67119,{"lat":101,"lon":100},[104,108],{"name":105,"role":39,"phone":106,"phoneExt":25,"email":107},"Ryszard Gawda, MD, PhD","(+48) 774520745","centrum@usk.opole.pl",{"name":105,"role":66,"phone":25,"phoneExt":25,"email":25},{"facility":110,"status":49,"city":111,"state":25,"zip":112,"country":52,"countryCode":53,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach","Zabrze","41-800",{"type":55,"coordinates":114},[115,116],18.78576,50.32492,{"lat":116,"lon":115},[119,123],{"name":120,"role":39,"phone":121,"phoneExt":25,"email":122},"Szymon Białka, MD, PhD","(+48) 323704307","sekretariat@szpital.zabrze.pl",{"name":120,"role":66,"phone":25,"phoneExt":25,"email":25},{"type":66,"investigatorFullName":125,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Wojciech Szczeklik","Professor of Medical Sciences, Head of the Department of Intensive Care and Perioperative Medicine Faculty",[128],{"name":129,"class":130},"Medical Research Agency, Poland","OTHER_GOV","100584125","phase-3-noradrenaline-versus-standard-blood-pressure-management-for-perioperative-hypotension-in-non-cardiac-surgery-100584125",false,"NCT06885268","Noradrenaline Versus Standard Blood Pressure Management for Perioperative Hypotension in Non-cardiac Surgery","The Effect of Noradrenaline Infusion Versus Standard Blood Pressure Management on Perioperative HYPotension in NOn-caRdiac Surgery HYP-NOR Trial","HYP-NOR","Inclusion Criteria:\n\n1. ≥45 years old\n2. Elective or accelerated\\* non-cardiac surgery expected to last ≥1 hour and requiring general, neuraxial, or combined general with neuraxial anesthesia\n3. Expected to stay overnight in the hospital after surgery\n4. Written informed consent to participate in the HYP-NOR Trial provided\n5. American Society of Anesthesiologists (ASA) physical status class II or higher.\n\nExclusion Criteria:\n\n1. Newly diagnosed, untreated, or uncontrolled hypertension -in two measurements on the day before surgery Systolic Blood Pressure (SBP) ≥180 mm Hg or Diastolic Blood Pressure (DBP) ≥110 mm Hg\n2. Persistent difference in recorded SBP between right and left upper limb \\>10 mm Hg\n3. Persistent atrial fibrillation\n4. Have a documented history of dementia\n5. Have language, vision, or hearing impairments that may compromise cognitive assessments\n6. Have a condition that precludes routine blood pressure management such as surgeon request for relative hypotension\n7. Receiving irreversible nonselective monoamine oxidase inhibitors (e.g. tranylcypromine, phenelzine) within 2 weeks preceding study enrolment\n8. The use of tricyclic antidepressants\n9. Have Prinzmetal angina\n10. Have contraindications to noradrenaline per clinician judgement\n11. Noradrenaline infusion started before surgery or plan to use continuous noradrenaline infusion throughout the procedure\n12. Treating physician (surgeon\u002Fanaesthetist) decides on the necessity of extended continuous hemodynamic monitoring during or after surgery\n13. Severe kidney disease (MDRD creatinine clearance \\\u003C15 mL\u002Fmin\u002F1.73m2) or renal replacement therapy\n14. End-stage heart failure: defined as NYHA Class IV - severe limitations in daily activity. Patients experience symptoms even while at rest. Mostly bedbound patients.\n15. Known severe liver disease: defined as the presence of liver cirrhosis or any of the symptoms of severe liver dysfunction: portal hypertension (esophageal varices, ascites), hepatocellular insufficiency (e.g., jaundice, hepatic encephalopathy) and coagulopathy (prolonged INR\u002FAPTT associated with known liver dysfunction).\n16. Emergency and urgent surgery defined as performed within 24 hours of sudden illness\u002Funplanned admission to hospital\n17. Have previously participated in the trial: patient already took a part in the HYP-NOR trial in the past\n18. Pregnant or breastfeeding women.","ALL","45 Years",{"count":142,"type":143},750,"ESTIMATED","INTERVENTIONAL",[146],"PHASE3","The effect of noradrenaline infusion versus standard blood pressure management on perioperative HYPotension in NOn-caRdiac surgery.\n\nThe study aims to determine whether perioperative noradrenaline infusion is superior to standard blood pressure management for the occurrence of perioperative hypotension.",[149,150,151],"Blood Pressure Management","Intraoperative Hypotension","Non-cardiac Surgery",[153,154,155],"hypotension","noradrenaline infusion","perioperative care","2026-01-12",{"date":158,"type":159},"2026-01-14","ACTUAL",{"date":161,"type":159},"2025-06-25",{"date":163,"type":143},"2027-06-30",{"name":5,"class":6},5]