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The effect of noradrenaline infusion versus standard blood pressure management on perioperative HYPotension in NOncaRdiac surgery.
EU CTIS ID: 2023-508255-39-00
What this study is testing
The study aims to determine whether perioperative noradrenaline infusion is superior to standard blood pressure management for the occurrence of perioperative hypotension in patients having noncardiac surgery.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥45years old
- Elective or accelerated* for noncardiac surgery expected to last ≥ 1 hour and requiring general, neuraxial, or combined general & neuraxial anaesthesia
- Expected to require at least overnight hospital stay
- Written informed consent to participate in the HYP-NOR Trial provided
- American Society of Anesthesiologists (ASA) physical status class II or higher.
You likely can't join if
- 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
- Receiving irreversible nonselective monoamine oxidase inhibitors (e.g. tranylcypromine, phenelzine) within 2 weeks preceding study enrolment
- Have contraindications to noradrenaline per clinician judgement
- Noradrenaline infusion started before surgery or plan to use continuous noradrenaline infusion throughout the procedure
- Treating physician (surgeon/anaesthetist) decides on the necessity of extended continuous hemodynamic monitoring during or after surgery
- Severe kidney disease (MDRD creatinine clearance <15 mL/min/1.73m2) or renal replacement therapy
See the full eligibility criteria
- ≥45years old
- Elective or accelerated* for noncardiac surgery expected to last ≥ 1 hour and requiring general, neuraxial, or combined general & neuraxial anaesthesia
- Expected to require at least overnight hospital stay
- Written informed consent to participate in the HYP-NOR Trial provided
- American Society of Anesthesiologists (ASA) physical status class II or higher.
- 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
- Receiving irreversible nonselective monoamine oxidase inhibitors (e.g. tranylcypromine, phenelzine) within 2 weeks preceding study enrolment
- Have contraindications to noradrenaline per clinician judgement
- Noradrenaline infusion started before surgery or plan to use continuous noradrenaline infusion throughout the procedure
- Treating physician (surgeon/anaesthetist) decides on the necessity of extended continuous hemodynamic monitoring during or after surgery
- Severe kidney disease (MDRD creatinine clearance <15 mL/min/1.73m2) or renal replacement therapy
- Persistent difference in recorded SBP between right and left upper limb >10 mm Hg
- Persistent atrial fibrillation
- End-stage heart failure
- Known severe liver disease
- Emergency and urgent surgery defined as performed within 24 hours of sudden illness/unplanned admission to hospital
- Have previously participated in the trial
- Pregnant or breastfeeding women
- Have a documented history of dementia
- Have language, vision, or hearing impairments that may compromise cognitive assessments
- Have a condition that precludes routine blood pressure management such as surgeon request for relative hypotension
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.