Status:
RECRUITING
The Effect of Noradrenaline Infusion Versus Standard Blood Pressure Management on Perioperative HYPotension in NOn-caRdiac Surgery HYP-NOR Trial
Lead Sponsor:
Jagiellonian University
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
Hypotension
Non-cardiac Surgery
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
The effect of noradrenaline infusion versus standard blood pressure management on perioperative HYPotension in NOn-caRdiac surgery. The study aims to determine whether perioperative noradrenaline inf...
Detailed Description
Patients will receive either noradrenaline infusion or standard blood pressure management during and up to 4 hours after surgery. Patients and health care providers will not be blinded to patients' al...
Eligibility Criteria
Inclusion
- ≥45 years old
- Elective or accelerated\* non-cardiac surgery expected to last ≥1 hour and requiring general, neuraxial, or combined general with neuraxial anesthesia
- Expected to stay overnight in the hospital after surgery
- Written informed consent to participate in the HYP-NOR Trial provided
- American Society of Anesthesiologists (ASA) physical status class II or higher.
Exclusion
- 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
- Persistent difference in recorded SBP between right and left upper limb \>10 mm Hg
- Persistent atrial fibrillation
- Have a documented history of dementia
- Have language, vision, or hearing impairments that may compromise cognitive assessments
- Have a condition that precludes routine blood pressure management such as surgeon request for relative hypotension
- Receiving irreversible nonselective monoamine oxidase inhibitors (e.g. tranylcypromine, phenelzine) within 2 weeks preceding study enrolment
- The use of tricyclic antidepressants
- Have Prinzmetal angina
- Have contraindications to noradrenaline per clinician judgement
- Noradrenaline infusion started before surgery or plan to use continuous noradrenaline infusion throughout the procedure
- Treating physician (surgeon/anaesthetist) decides on the necessity of extended continuous hemodynamic monitoring during or after surgery
- Severe kidney disease (MDRD creatinine clearance \<15 mL/min/1.73m2) or renal replacement therapy
- End-stage heart failure: defined as NYHA Class IV - severe limitations in daily activity. Patients experience symptoms even while at rest. Mostly bedbound patients.
- 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).
- Emergency and urgent surgery defined as performed within 24 hours of sudden illness/unplanned admission to hospital
- Have previously participated in the trial: patient already took a part in the HYP-NOR trial in the past
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
March 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT06885268
Start Date
March 29 2025
End Date
June 30 2027
Last Update
November 20 2025
Active Locations (5)
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1
Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibińskiego Śląski Uniwersytet Medyczny
Katowice, Poland, 40-752
2
5 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
Krakow, Poland, 30-901
3
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, Poland, 10-561
4
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Poland, 45-401