Noradrenaline versus usual blood pressure care during non-cardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults having elective or accelerated non-cardiac surgery expected to last at least one hour are randomized to receive either a continuous perioperative noradrenaline infusion (continued up to four hours after surgery) or standard reactive blood pressure management. The trial is open-label to clinicians, while continuous non-invasive blood pressure is recorded covertly using a volume-clamp method and routine intermittent measurements guide care. All participants receive standardized intraoperative care including balanced crystalloids at 4 ml/kg/hour and recommended tidal volumes of 8 ml/kg predicted body weight, with attention to volume status, depth of anaesthesia, positioning, and prompt treatment of reversible causes of hypotension. The primary aim is to see whether proactive noradrenaline reduces the duration and severity of perioperative hypotension compared with reactive treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibińskiego Śląski Uniwersytet Medyczny
  Katowice, Poland Recruiting
• 5 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
  Krakow, Poland Recruiting
• Uniwersytecki Szpital Kliniczny w Opolu
  Opole, Poland Recruiting
• Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach
  Zabrze, Poland Recruiting
• Wojewódzki Szpital Specjalistyczny w Olsztynie
  Olsztyn, Poland Active not recruiting

Study contacts

• Study coordinator: Bożena Seczyńska, PhD
• Email: bozena.seczynska@uj.edu.pl
• Phone: (+48) 124332847

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.