HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients: The HISTAP Randomized Clinical Trial.

HISTAP TRIAL

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.

2023-03-06

2024-12-31

2025-01-31

Recruiting

636

Inclusion criteria (all the following) 1. Adult patients ≥ 60 years 2. History of chronic hypertension requiring home therapy. 3. Scheduled for major elective abdominal surgery (laparoscopic, robotic or laparotomic) 4. Expected surgical duration of at least 3 hours. 5. 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): 1. American Society of Anesthesiologists (ASA) class 3 or 4 2. Known or documented history of coronary artery disease (angina, myocardial infarction or acute coronary syndrome). 3. Known or documented history of peripheral vascular disease. 4. Known or documented history of heart failure requiring treatment. 5. Ejection fraction less than 30% (echocardiography) 6. Signs of diastolic moderate to severe dysfunction or chronic hypertensive cardiomyopathy (echocardiography) 7. Moderate or severe valvular heart disease (echocardiography) 8. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Radiographically confirmed or according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. 9. Diabetes currently treated with an oral hypoglycemic agent and/or insulin 10. Morbid obesity (BMI ≥35 kg/m2) 11. Preoperative serum albumin \<30 g/l 12. Anaerobic threshold (if done) \<14 ml/kg/min 13. Exercise tolerance equivalent to six metabolic equivalents (METs) or less as defined by American College of Cardiology/American Heart Association guidelines Exclusion criteria 1. Refusal of consent 2. Chronic kidney disease with glomerular filtration rate \<30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease 3. Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome (within prior 30 days). 4. Urgent or time-critical surgery 5. Aortic or Renal vascular surgery (including nephrectomy) 6. Liver Surgery 7. Neurosurgery 8. Surgery for palliative treatment only or ASA physical status 5 9. Pregnancy

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be a multicentric, randomized, non-blinded clinical trial. Eligible patients will be assigned in a 1:1 ratio to either a to control or treatment group. Randomization list will be created by a computer with the use of a permuted block design and embedded in the Electronic Case Report Form. Randomization will be performed using a \'block of 6" and stratified according to predefined baseline characteristics:\n\n1. Age ≥ 75 years\n2. Preoperative systolic pressure\n\n 1. \\< 140 mmHg\n 2. ≥ 140 mmHg', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The trial intervention is not blinded for investigators, clinical staff, and patients, as blinding intraoperative MAP target is not feasible. The physicians of each center assessing all postoperative outcomes will be masked for the allocation.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 636, 'type': 'ESTIMATED'}}

2024-05-23