The Effect of Noradrenaline Infusion Versus Standard Blood Pressure Management on Perioperative HYPotension in NOn-caRdiac Surgery HYP-NOR Trial

Launched by JAGIELLONIAN UNIVERSITY · Mar 17, 2025

Keywords

ClinConnect Summary

The HYP-NOR Trial is a clinical study that aims to find out if using noradrenaline, a medication that helps raise blood pressure, is more effective than standard methods in preventing low blood pressure (hypotension) during and after non-cardiac surgeries. This trial is important because maintaining stable blood pressure during surgery can help ensure better outcomes for patients.

To take part in this study, participants need to be at least 45 years old and scheduled for elective (planned) non-cardiac surgery that lasts at least an hour. They should also be expected to stay in the hospital overnight after the procedure. However, not everyone will qualify; individuals with certain health conditions, such as untreated high blood pressure or severe heart and kidney issues, will be excluded. If eligible, participants can expect to receive careful monitoring and treatment during their surgery to help manage their blood pressure. The study is currently not recruiting participants, but it hopes to provide valuable information about how to improve care during surgery in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ≥45 years old
• • 2. Elective or accelerated\* non-cardiac surgery expected to last ≥1 hour and requiring general, neuraxial, or combined general with neuraxial anesthesia
• • 3. Expected to stay overnight in the hospital after surgery
• • 4. Written informed consent to participate in the HYP-NOR Trial provided
• • 5. American Society of Anesthesiologists (ASA) physical status class II or higher.
• Exclusion Criteria:
• • 1. 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
• • 2. Persistent difference in recorded SBP between right and left upper limb \>10 mm Hg
• • 3. Persistent atrial fibrillation
• • 4. Have a documented history of dementia
• • 5. Have language, vision, or hearing impairments that may compromise cognitive assessments
• • 6. Have a condition that precludes routine blood pressure management such as surgeon request for relative hypotension
• • 7. Receiving irreversible nonselective monoamine oxidase inhibitors (e.g. tranylcypromine, phenelzine) within 2 weeks preceding study enrolment
• • 8. The use of tricyclic antidepressants
• • 9. Have Prinzmetal angina
• • 10. Have contraindications to noradrenaline per clinician judgement
• • 11. Noradrenaline infusion started before surgery or plan to use continuous noradrenaline infusion throughout the procedure
• • 12. Treating physician (surgeon/anaesthetist) decides on the necessity of extended continuous hemodynamic monitoring during or after surgery
• • 13. Severe kidney disease (MDRD creatinine clearance \<15 mL/min/1.73m2) or renal replacement therapy
• • 14. End-stage heart failure: defined as NYHA Class IV - severe limitations in daily activity. Patients experience symptoms even while at rest. Mostly bedbound patients.
• • 15. 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/APTT associated with known liver dysfunction).
• • 16. Emergency and urgent surgery defined as performed within 24 hours of sudden illness/unplanned admission to hospital
• • 17. Have previously participated in the trial: patient already took a part in the HYP-NOR trial in the past
• • 18. Pregnant or breastfeeding women.