HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery (HISTAP)
Blood Pressure, Complication,Postoperative, Intraoperative Hypotension
About this trial
This is an interventional treatment trial for Blood Pressure focused on measuring Blood pressure, Intraoperative Hypotension, Postoperative complications, Postoperative mortality
Eligibility Criteria
Inclusion criteria (all the following) Adult patients ≥ 60 years History 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. AND At increased risk of postoperative complications (at least one of the following): American Society of Anesthesiologists (ASA) class 3 or 4 Known 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 insulin Morbid obesity (BMI ≥35 kg/m2) Preoperative serum albumin <30 g/l Anaerobic threshold (if done) <14 ml/kg/min Exercise tolerance equivalent to six metabolic equivalents (METs) or less as defined by American College of Cardiology/American Heart Association guidelines Exclusion criteria Refusal of consent Chronic kidney disease with glomerular filtration rate <30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome (within prior 30 days). Urgent or time-critical surgery Aortic or Renal vascular surgery (including nephrectomy) Liver Surgery Neurosurgery Surgery for palliative treatment only or ASA physical status 5 Pregnancy
Sites / Locations
- Department of Anesthesia, Critical Care and Pain Medicine, SS. Annunziata Hospital
- Department of Anesthesia and Intensive Care, University Hospital of Modena
- Policlinico A. Gemelli
- Humanitas Research HospitalRecruiting
- Ospedali Riuniti Foggia- Università di FoggiaRecruiting
- Fondazione Istituto San Raffaele G. GiglioRecruiting
- Division of Anesthesia and Intensive Care, University of Messina, Policlinico "G. Martino"
- Department of Surgical Oncological and Oral Science, University of Palermo
- Careggi University HospitalRecruiting
- Unit of Anesthesiology and Intensive Care B, Department of Surgery, Dentistry, Gynecology and Pediatrics, AOUI-University Hospital Integrated Trust of Verona
Arms of the Study
Arm 1
Arm 2
Experimental
Other
MAP 80
MAP 65
Intervention group: intraoperative mean blood pressure target > 80 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 80 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values.
Control group: intraoperative mean blood pressure target > 65 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 65 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values.