Actively Recruiting
The Effect of Noradrenaline Infusion Versus Standard Blood Pressure Management on Perioperative Hypotension in Non-cardiac Surgery HYP-NOR Trial
Led by Jagiellonian University · Updated on 2026-01-14
750
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Jagiellonian University
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether infusing noradrenaline around the time of non-cardiac surgery can better prevent low blood pressure (hypotension) compared to standard blood pressure management. The study focuses on patients aged 45 and older undergoing elective or accelerated non-cardiac surgery lasting at least one hour. It investigates if noradrenaline infusion reduces episodes of low blood pressure during and up to four hours after surgery, and whether it lowers risks of postoperative organ problems or complications. Participants will be randomly assigned to one of two groups. One group receives a noradrenaline infusion starting shortly before anesthesia induction, maintained during surgery and up to four hours after, with careful dose adjustments to maintain stable blood pressure. The other group receives standard blood pressure management, reacting to low blood pressure using ephedrine boluses or noradrenaline as needed, following current guidelines. All patients receive balanced fluids during surgery and standard ventilatory support. Blood pressure is continuously monitored using a non-invasive volume-clamp method, while clinical teams use routine measurements for care decisions. During the study, participants will have their blood pressure closely tracked during surgery and in the recovery area. Researchers will assess occurrences of low blood pressure during and up to four hours after surgery, as well as various postoperative complications including heart injury, kidney injury, stroke, cardiac arrest, sepsis, and death, monitored up to 30 days after surgery. Safety assessments include reactions related to the noradrenaline infusion. Participants are expected to stay overnight in the hospital, and the study ensures careful monitoring of hemodynamic stability throughout the perioperative period.
CONDITIONS
Brief Title
Noradrenaline Versus Standard Blood Pressure Management for Perioperative Hypotension in Non-cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 45 years old or older
- Undergoing elective or accelerated non-cardiac surgery expected to last at least 1 hour
- Expected to stay overnight in the hospital after surgery
- Able to provide written informed consent to participate
- Classified as American Society of Anesthesiologists (ASA) physical status class II or higher
You will not qualify if you...
- Newly diagnosed, untreated, or uncontrolled hypertension with systolic blood pressure 180 mm Hg or higher or diastolic blood pressure 110 mm Hg or higher on the day before surgery
- Persistent difference in systolic blood pressure greater than 10 mm Hg between right and left upper limbs
- Persistent atrial fibrillation
- Documented history of dementia
- Language, vision, or hearing impairments that may affect cognitive assessments
- Conditions preventing routine blood pressure management, such as surgeon request for relative hypotension
- Use of irreversible nonselective monoamine oxidase inhibitors within 2 weeks before enrollment
- Use of tricyclic antidepressants
- Diagnosis of Prinzmetal angina
- Contraindications to noradrenaline as judged by clinician
- Noradrenaline infusion started before surgery or planned continuous infusion throughout procedure
- Treating physician requires extended continuous hemodynamic monitoring during or after surgery
- Severe kidney disease with creatinine clearance below 15 mL/min/1.73m2 or on renal replacement therapy
- End-stage heart failure classified as NYHA Class IV
- Known severe liver disease with symptoms like portal hypertension or liver dysfunction
- Emergency or urgent surgery performed within 24 hours of sudden illness or hospital admission
- Previous participation in this trial
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During surgery and up to 4 hours after surgery
Participants receive either a noradrenaline infusion starting just before anesthesia induction and continuing during surgery and up to 4 hours after, or standard blood pressure management reactive to blood pressure values throughout surgery and up to 4 hours postoperatively.
Continuous monitoring during surgery and postoperatively up to 4 hours
Duration - Up to 30 days after surgery
Participants are monitored for safety and outcomes including postoperative organ dysfunction, infusion-related reactions, and other complications for up to 30 days after surgery.
Follow-up visits during hospitalization and assessments up to 30 days after surgery
Trial Site Locations
Total: 5 locations
1
Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibińskiego Śląski Uniwersytet Medyczny
Katowice, Poland, 40-752
Actively Recruiting
2
5 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
Krakow, Poland, 30-901
Actively Recruiting
3
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, Poland, 10-561
Active, Not Recruiting
4
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Poland, 45-401
Actively Recruiting
5
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach
Zabrze, Poland, 41-800
Actively Recruiting
Research Team
B
Bożena Seczyńska, PhD
Z
Zbigniew Putowski, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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