A Phase 3 interventional study of noradrenaline infusion for management blood pressure and standard blood pressure management in Blood Pressure Management, Intraoperative Hypotension and Non-cardiac Surgery, sponsored by Jagiellonian University. Recruiting at 5 sites in Poland. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Jagiellonian University · Phase 3, Interventional, and Treatment
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.
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 the operating room, and at least every 15 minutes in the post-anaesthesia care unit . 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.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's planned enrollment of 750 is above the median of 87 across 590 interventional studies indexed under Hypotension.
Browse Hypotension studies →Jagiellonian University is the lead sponsor of 161 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the intervention group, a standardized noradrenaline infusion at a concentration of 10 µg/mL will be initiated 15 to 60 seconds before induction of anaesthesia. The infusion will be titrated and maintained during surgery and postoperatively for up to 4 hours, with a minimum duration of 2 hours, until haemodynamic stability is achieved. Haemodynamic stability is defined as stable blood pressure requiring minimal noradrenaline support of 0.01 µg/kg/min or less for at least 1 hour. We will mandate avoidance of mean arterial pressure decreasing below 60 to 70 mm Hg. Once haemodynamic stability is achieved during the postoperative observation period, noradrenaline infusion may be discontinued. Safety criteria for discontinuation include systolic blood pressure above 180 mm Hg, in which case the infusion will be stopped. If systolic blood pressure is between 140 and 170 mm Hg, dose reduction or continuation at a very low noradrenaline infusion of 0.005 µg/kg/min, approximately 1 mL per h
Drug: noradrenaline infusion for management blood pressure
Standard blood pressure management reactive to blood pressure values. According to the 2022 ESA/ESC guidelines, patients in the control group will be treated to avoid a mean arterial pressure below 60 to 70 mm Hg. Ephedrine boluses (5 mg per bolus, up to a total intravenous dose of 25 mg) are recommended as first line treatment for hypotension. If hypotension persists, peripheral noradrenaline may be administered. Due to variability in clinical practice regarding the choice and timing of vasopressors and fluid therapy during and after surgery, further protocolization of hypotension management will not be mandated in order to enhance feasibility and generalizability of the trial.
Combination Product: standard blood pressure management
A single concentration of noradrenaline (10 μg/ml) will be initiated 15-60 seconds prior to the induction of anaesthesia, then titrated and maintained until 4 hours after surgery to meet pre-specified mean arterial pressure (MAP) targets. The drug infusion will be started at a dose of 0.01 μg/kg/min and will be titrated to a maximum of 0.1 μg/kg/min. Anaesthesiologists will be advised to use the lowest possible dose of noradrenaline. Avoidance of MAP decreases of \>20% from baseline values or \<60-70 mm Hg will be required in both groups. Individual baseline MAP value will be defined as resting blood pressure obtained in at least two measurements at the surgery ward on the day before surgery. Noradrenaline will be administered peripherally in all patients who do not have a central venous catheter in place.
Patients in the control group will receive standard blood pressure management reactive to blood pressure values. In the light of the current ESA/ESC 2022 guidelines, all patients in the control group will be treated to avoid MAP \<60-70 mm Hg. Ephedrine boluses (5 mg each, up to 25 mg total intravenous dose) will be recommended as a first-line hypotension treatment. Subsequent treatment will involve administering peripheral noradrenaline. Notwithstanding, there is a variation in clinical practice regarding the choice and timing of vasopressors and fluids to be administered during and after surgery, therefore, hypotension treatment will not be further protocolized to increase the feasibility and generalizability of the trial.
Perioperative hypotension
Number of episodes of perioperative hypotension defined as any mean arterial pressure (MAP) reading ≤55 mm Hg in the setting of a continuous blood pressure measurement.
Time frame: During and up to 4 hours after surgery
Myocardial Injury after Non-cardiac Surgery (MINS)
Number of patients who experience MINS defined as any myocardial infarction and any acutely elevated postoperative cardiac troponin judged as resulting from myocardial ischemia using Roche's fifth generation Elecsys hsTnT, with an established cut-off of 20 ng/L combined with an absolute change of 5 ng/L or more (judged as due to ischemia)
Time frame: During hospitalization and up to 30 days after surgery
Acute kidney injury fulfilling Kidney Disease Improving Global Outcomes (KDIGO) criteria
Number of patients who experience an acute kidney injury (fulfilling KDIGO criteria)
Time frame: During hospitalization and up to 30 days after surgery
Stroke
Number of patients who experience a stroke is defined as a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting more than 24 hours or leading to death. Stroke will be sub-classified into hemorrhagic and non-hemorrhagic stroke.
Time frame: During hospitalization and up to 30 days after surgery
Non-fatal cardiac arrest
Number of patients who experience non-fatal cardiac arrest defined as successful resuscitation from either documented or presumed ventricular fibrillation, sustained ventricular tachycardia, asystole, or pulseless electrical activity (PEA) requiring cardiopulmonary resuscitation, pharmacological therapy, or cardiac defibrillation
Time frame: During hospitalization and up to 30 days after surgery
Sepsis
Number of patients who experience sepsis is defined as an increase in SOFA score of 2 or more, with evidence of infection. This outcome includes septic shock defined as sepsis with shock (vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mM \[above18 mg/dL\] in the absence of hypovolemia). Infection is defined as a pathologic process caused by the invasion of normally sterile tissue or fluid or body cavity by pathogenic or potentially pathogenic organisms.
Time frame: During hospitalization and up to 30 days after surgery
Death
Number of patients who die of any cause
Time frame: During hospitalization and up to 30 days after surgery
Infusion-related reactions
The number of patients who experience infusion-related reactions, defined as disorders such as flushing, rash, fever, rigors, chills, dyspnoea, bronchospasms, cardiac dysfunction, and anaphylaxis. Grades of infusion site extravasation are defined according to the Common Terminology Criteria for Adverse Events.
Time frame: During the infusion of noradrenaline and up to 30 days after drug administration, with assessment occurring postoperatively.
Days alive and out of hospital
Number of days when a patient is alive and out of hospital
Time frame: 30 days after surgery
Clinically important atrial fibrillation
Number of patients who experience clinically important atrial fibrillation, defined as new-onset atrial fibrillation or atrial flutter of any duration on an ECG or rhythm strip, which results in angina, congestive heart failure, symptomatic hypotension, or requires treatment with a rate-controlling drug, antiarrhythmic drug, or electrical cardioversion
Time frame: During hospitalization and up to 30 days after surgery
Major bleeding
Number of patients who experience an International Society on Thrombosis and Haemostasis (ISTH) major bleeding
Time frame: During hospitalization and up to 30 days after surgery
Peripheral ischemia
Number of patients who experience peripheral ischemia defined as the fingertip necrosis of upper and lower limbs
Time frame: During hospitalization and up to 30 days after surgery
Lowest MAP throughout the procedure
Number of patients who experience the lowest MAP throughout the procedure, defined as the lowest punctual measurement of mean arterial pressure
Time frame: During surgery
Median mean arterial pressure
Time frame: During and up to 4 hours after surgery
Median heart rate
Time frame: During and up to 4 hours after surgery
Acute Myocardial Infarction
Number of patients who experience acute myocardial injury according to the Fourth Universal Definition of Myocardial Infarction as a detection of an elevated cTn value above the 99th percentile URL with a rise and/or fall of cTn values.
Time frame: During hospitalization and up to 30 days after surgery
Peak troponin concentration
Peak troponin concentration
Time frame: The first three days after surgery
Area under the curve troponin
Area under the curve troponin is defined as total cTn release measured as area under the Troponin-Time curve
Time frame: The first three days after surgery
Bradycardia
Number of patients who experience bradycardia, defined as a heart rate less than 40 beats per minute
Time frame: During surgery, up to 4 hours after surgery, and up to 30 days after surgery.
Acute congestive heart failure
Number of patients who experience acute congestive heart failure defined as an episode characterized by at least one of the following clinical signs (i.e. any of the following signs: elevated jugular venous pressure, respiratory rales/crackles, crepitations, or presence of S3) and at least one of the following: (I) Radiographic findings (i.e. vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema) OR (II) Heart failure treatment implemented with diuretics with documented clinical improvement
Time frame: During hospitalization and up to 30 days after surgery
Acute Kidney Injury stage 2-3
Number of patients who experience acute kidney injury stage 2-3 according to KDIGO criteria
Time frame: 30 days after surgery
Pneumonia
Number of patients who experience pneumonia, defined according to the US Centers for Disease Control criteria
Time frame: During hospitalization and up to 30 days after surgery
Postoperative pulmonary complications
Number of patients who experience postoperative pulmonary complications which are a composite outcome comprised of the following outcomes: 1. Atelectasis detected on computed tomography or chest radiograph 2. Pneumonia using US Centers for Disease Control criteria 3. Acute respiratory distress syndrome (according to Berlin definition) 4. Pulmonary aspiration (clear clinical history AND radiological evidence)
Time frame: During hospitalization and up to 30 days after surgery
Surgical site infection
Number of patients who experience surgical site infection defined according to the Centers for Disease Control and Prevention (CDC) criteria
Time frame: During hospitalization and up to 30 days after surgery
Postoperative delirium
Number of patients who experience delirium (based on The Nursing Delirium Screening Scale - NuDESC). A total score of 2 or higher on the scale indicates a positive result for the diagnosis of delirium.
Time frame: Assessment on postoperative days 1, 2, 3
Discharge destination
Number of patients discharged from the hospital to home/long-term care facility/other
Time frame: 30 days after surgery
Days alive and outside the intensive care unit
Number of days when a patient is alive and outside the intensive care unit
Time frame: 30 days after surgery
Health-related quality of life
Health-related quality of life will be evaluated (based on the EuroQol 5 Dimension, five-level version \[EQ-5D\]), compared to the assessment made after consent and before randomization.
Time frame: 30 days after surgery
Lowest MAP during the 4 hours postoperative period
The lowest recorded mean arterial pressure during postoperative monitoring lasting at least 2 hours and up to 4 hours after surgery.
Time frame: up to 4 hours after surgery
Perioperative myocardial infarction/injury
Number of Participants with Perioperative myocardial infarction/injury as defined by the 2022 European Society of Cardiology (ESC) Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery: an absolute increase in hs-cTn concentration of more than the 99th percentile URL after surgery compared to the pre-operative level. In the absence of a preoperative hs-cTn T/I concentration, a hs-cTn more than five-times the 99th percentile URL or an absolute increase or decrease more than the 99th percentile URL
Time frame: up to 72 hours (3 days) postoperatively
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