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NCT05637606
HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery
Conditions: Blood Pressure, Complication,Postoperative, Intraoperative Hypotension
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 636
Sponsor: Humanitas Clinical and Research Center
Location: Italy
Summary
This study is a multicenter randomized controlled trial comparing two strategies of mean arterial blood pressure management (MAP ≥ 80mmHg vs MAP ≥ 65 mmHg) in high-risk surgical patients undergoing elective laparotomic/laparoscopic surgery.
Eligibility Criteria
Inclusion criteria (all the following)Adult patients ≥ 60 yearsHistory of chronic hypertension requiring home therapy.Scheduled for major elective abdominal surgery (laparoscopic, robotic or laparotomic)Expected surgical duration of at least 3 hours.Needing invasive arterial and hemodynamic monitoring as decided by the attending anesthetist, according to the rules of good clinical practice of each involved center.ANDAt increased risk of postoperative complications (at least one of the following):American Society of Anesthesiologists (ASA) class 3 or 4Known or documented history of coronary artery disease (angina, myocardial infarction or acute coronary syndrome).Known or documented history of peripheral vascular disease.Known or documented history of heart failure requiring treatment.Ejection fraction less than 30% (echocardiography)Signs of diastolic moderate to severe dysfunction or chronic hypertensive cardiomyopathy (echocardiography)Moderate or severe valvular heart disease (echocardiography)Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Radiographically confirmed or according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.Diabetes currently treated with an oral hypoglycemic agent and/or insulinMorbid obesity (BMI ≥35 kg/m2)Preoperative serum albumin <30 g/lAnaerobic threshold (if done) <14 ml/kg/minExercise tolerance equivalent to six metabolic equivalents (METs) or less as defined by American College of Cardiology/American Heart Association guidelinesExclusion criteriaRefusal of consentChronic kidney disease with glomerular filtration rate <30 ml/min/1.73
m2 or requiring renal-replacement therapy for end-stage renal diseaseAcute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome (within prior 30 days).Urgent or time-critical surgeryAortic or Renal vascular surgery (including nephrectomy)Liver SurgeryNeurosurgerySurgery for palliative treatment only or ASA physical status 5Pregnancy
Source: ClinicalTrials.gov (NCT05637606). StuddyBuddy aggregates publicly available trial information.