Phase
Condition
Dizzy/fainting Spells
Vascular Diseases
Circulation Disorders
Treatment
noradrenaline infusion for management blood pressure
standard blood pressure management
Clinical Study ID
Ages > 45 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥45 years old
Elective or accelerated* non-cardiac surgery expected to last ≥1 hour and requiringgeneral, 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
American Society of Anesthesiologists (ASA) physical status class II or higher.
Exclusion
Exclusion Criteria:
Newly diagnosed, untreated, or uncontrolled hypertension -in two measurements on theday before surgery Systolic Blood Pressure (SBP) ≥180 mm Hg or Diastolic BloodPressure (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
Have language, vision, or hearing impairments that may compromise cognitiveassessments
Have a condition that precludes routine blood pressure management such as surgeonrequest for relative hypotension
Receiving irreversible nonselective monoamine oxidase inhibitors (e.g.tranylcypromine, phenelzine) within 2 weeks preceding study enrolment
The use of tricyclic antidepressants
Have Prinzmetal angina
Have contraindications to noradrenaline per clinician judgement
Noradrenaline infusion started before surgery or plan to use continuousnoradrenaline infusion throughout the procedure
Treating physician (surgeon/anaesthetist) decides on the necessity of extendedcontinuous hemodynamic monitoring during or after surgery
Severe kidney disease (MDRD creatinine clearance <15 mL/min/1.73m2) or renalreplacement therapy
End-stage heart failure: defined as NYHA Class IV - severe limitations in dailyactivity. Patients experience symptoms even while at rest. Mostly bedbound patients.
Known severe liver disease: defined as the presence of liver cirrhosis or any of thesymptoms of severe liver dysfunction: portal hypertension (esophageal varices,ascites), hepatocellular insufficiency (e.g., jaundice, hepatic encephalopathy) andcoagulopathy (prolonged INR/APTT associated with known liver dysfunction).
Emergency and urgent surgery defined as performed within 24 hours of suddenillness/unplanned admission to hospital
Have previously participated in the trial: patient already took a part in theHYP-NOR trial in the past
Pregnant or breastfeeding women.
Study Design
Study Description
Connect with a study center
Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibińskiego Śląski Uniwersytet Medyczny
Katowice, 40-752
PolandSite Not Available
5 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
Kraków, 30-901
PolandSite Not Available
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10-561
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45-401
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach
Zabrze, 41-800
PolandSite Not Available
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