Noradrenaline Versus Standard Blood Pressure Management for Perioperative Hypotension in Non-cardiac Surgery

ConditionsBlood Pressure Management Intraoperative Hypotension Non-cardiac Surgery

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age45+

SponsorJagiellonian University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

noradrenaline infusion for management blood pressure
Drug
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.
standard blood pressure management
Combination product
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.

Treatment groups

750 Participants

are divided into 2 treatment groups

Group A: Intervention groupActive comparator 1 intervention

Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jagiellonian University

Lead sponsor

Medical Research Agency, Poland

Collaborator

Source ClinicalTrials.gov

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