HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Ab… (NCT05637606) | Clinical Trial Compass
CompletedNot Applicable
HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery
Italy636 participantsStarted 2023-03-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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.
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)
What they're measuring
1
Composite endpoint of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes).