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

Last updated: March 17, 2025
Sponsor: Jagiellonian University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Dizzy/fainting Spells

Vascular Diseases

Circulation Disorders

Treatment

noradrenaline infusion for management blood pressure

standard blood pressure management

Clinical Study ID

NCT06885268
HYP-NOR
2023-508255-39-00
  • Ages > 45
  • All Genders

Study 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 infusion is superior to standard blood pressure management for the occurrence of perioperative hypotension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥45 years old

  2. Elective or accelerated* non-cardiac surgery expected to last ≥1 hour and requiringgeneral, 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

Exclusion Criteria:

  1. Newly diagnosed, untreated, or uncontrolled hypertension -in two measurements on theday before surgery Systolic Blood Pressure (SBP) ≥180 mm Hg or Diastolic BloodPressure (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 cognitiveassessments

  6. Have a condition that precludes routine blood pressure management such as surgeonrequest 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 continuousnoradrenaline infusion throughout the procedure

  12. Treating physician (surgeon/anaesthetist) decides on the necessity of extendedcontinuous hemodynamic monitoring during or after surgery

  13. Severe kidney disease (MDRD creatinine clearance <15 mL/min/1.73m2) or renalreplacement therapy

  14. End-stage heart failure: defined as NYHA Class IV - severe limitations in dailyactivity. 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 thesymptoms of severe liver dysfunction: portal hypertension (esophageal varices,ascites), hepatocellular insufficiency (e.g., jaundice, hepatic encephalopathy) andcoagulopathy (prolonged INR/APTT associated with known liver dysfunction).

  16. Emergency and urgent surgery defined as performed within 24 hours of suddenillness/unplanned admission to hospital

  17. Have previously participated in the trial: patient already took a part in theHYP-NOR trial in the past

  18. Pregnant or breastfeeding women.

Study Design

Total Participants: 750
Treatment Group(s): 2
Primary Treatment: noradrenaline infusion for management blood pressure
Phase: 3
Study Start date:
March 29, 2025
Estimated Completion Date:
June 30, 2027

Study 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' allocation to either arm of the trial. Continuous blood pressure measurements will be secured in all patients who do not have an arterial line already in place for other indications using a non-invasive volume-clamp method. The medical team will not be aware of the continuous blood pressure monitoring and will use solely non-invasive blood pressure measurements at time intervals (at least every 5 minutes). In each group, patients will receive balanced crystalloids at 4 ml/kg per hour as maintenance fluid during surgery. In mechanical ventilation, a tidal volume of 8 mL/kg predicted body weight will be recommended. Other ventilatory settings, optimisation of volume status, depth of anaesthesia, patient positioning, as well as prompt diagnosis and treatment of reversible causes of hypotension will be prioritised in all patients in adherence with institutional protocols and current standards of practice.

The study aims to determine whether perioperative noradrenaline infusion can reduce exposure to hypotension compared to reactive treatment of hypotension, whether it is more effective in controlling hypotension during the intraoperatively and postoperatively, whether it reduces the risk of postoperative organ dysfunction, and whether it is safe and does not increase the risk of potential complications.

Connect with a study center

  • Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibińskiego Śląski Uniwersytet Medyczny

    Katowice, 40-752
    Poland

    Site Not Available

  • 5 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie

    Kraków, 30-901
    Poland

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, 10-561
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole, 45-401
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach

    Zabrze, 41-800
    Poland

    Site Not Available

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