NOREPINEPHRINE for Perioperative hypotension|Intraoperative hypotension

Inclusion criteria

• {"criterion_text":"- ≥45years old\n- Elective or accelerated* for noncardiac surgery expected to last ≥ 1 hour and requiring general, neuraxial, or combined general & neuraxial anaesthesia\n- Expected to require at least overnight hospital stay\n- Written informed consent to participate in the HYP-NOR Trial provided\n- American Society of Anesthesiologists (ASA) physical status class II or higher."}

Exclusion criteria

• {"criterion_text":"- 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\n- Receiving irreversible nonselective monoamine oxidase inhibitors (e.g. tranylcypromine, phenelzine) within 2 weeks preceding study enrolment\n- Have contraindications to noradrenaline per clinician judgement\n- Noradrenaline infusion started before surgery or plan to use continuous noradrenaline infusion throughout the procedure\n- Treating physician (surgeon/anaesthetist) decides on the necessity of extended continuous hemodynamic monitoring during or after surgery\n- Severe kidney disease (MDRD creatinine clearance <15 mL/min/1.73m2) or renal replacement therapy\n- Persistent difference in recorded SBP between right and left upper limb >10 mm Hg\n- Persistent atrial fibrillation\n- End-stage heart failure\n- Known severe liver disease\n- Emergency and urgent surgery defined as performed within 24 hours of sudden illness/unplanned admission to hospital\n- Have previously participated in the trial\n- Pregnant or breastfeeding women\n- Have a documented history of dementia\n- Have language, vision, or hearing impairments that may compromise cognitive assessments\n- Have a condition that precludes routine blood pressure management such as surgeon request for relative hypotension"}

Primary endpoints

• {"endpoint_text":"- The primary outcome is perioperative hypotension, defined as any mean arterial pressure (MAP) reading ≤55 mmHg during and up to 4 hours after noncardiac surgery.","definition_or_measurement_approach":"Perioperative hypotension defined as any mean arterial pressure (MAP) reading ≤55 mmHg during and up to 4 hours after noncardiac surgery (MAP measurements intraoperatively and up to 4 hours postoperatively)."}

Secondary endpoints

• {"endpoint_text":"- Secondary outcomes include time under MAP ≤60 mm Hg intraoperatively and postoperatively; a composite of major perfusion-related complications: myocardial injury after noncardiac surgery (MINS), acute kidney injury (AKI), stroke, non-fatal cardiac arrest, sepsis, and death of all causes; infusion-related reactions; days alive and at home up to 30 days after surgery.","definition_or_measurement_approach":"Includes measurement of time under MAP ≤60 mm Hg intraoperatively and postoperatively; occurrence of composite perfusion-related complications (MINS, AKI, stroke, non-fatal cardiac arrest, sepsis, death); recording infusion-related reactions; and days alive and at home up to 30 days after surgery."}

Poland

Earliest CTIS Part Ii Submission Date

24-06-2024

Latest Decision Or Authorization Date

17-12-2025

Processing Time Days

541

Number Of Sites

6

Number Of Participants

750

Primary sponsor

Full Name

Uniwersytet Jagiellonski Collegium Medicum

Organisation Type

Educational Institution

Country Of Registered Address

Poland