Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery (PRECISE)

Meshalkin Research Institute of Pathology of Circulation

Status: Withdrawn

Conditions: Cardiac Surgery

Treatments: Other: Standard intraoperative BP management; Other: Individualized intraoperative BP management

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03784690

19

Details and patient eligibility

About

This pilot randomized-controlled study will determine the feasibility of large study comparing individualized versus standard blood pressure (BP) management in patients undergoing cardiac surgery under cardiopulmonary bypass (CPB). Our hypothesis is that maintaining higher BP levels based on preoperative measurements will reduce the incidence of major complications (composite outcome).

Full description

Adequate hemodynamic control is a cornerstone in management in patients undergoing different types of surgery. Among all perioperative risk factors, the association between perioperative hypotension and adverse clinical outcomes in noncardiac and cardiac surgery patients is well defined.

Numerous factors are responsible for development of perioperative hypotension. They include but not limited to perioperative use of renin-angiotensin-aldosterone system and calcium channel blockers, hypovolemia, hemodilution, bleeding and inflammatory response syndrome.

To date, several evidence has been accumulated indicating that intraoperational hypertension can be hazardous.

It was shown that even short durations (1 to 5 min) of an intraoperative mean arterial pressure < 55 mmHg were associated with myocardial injuries and acute kidney injury (AKI).

Results of recent large retrospective cohort study conducted in adult patients who underwent cardiac surgery requiring CPB showed that postoperative stroke was strongly associated with sustained mean arterial pressure of less than 64 mmHg during cardiopulmonary bypass.

In patients undergoing CABG the overall incidence of combined cardiac and neurologic complications was significantly lower in the group where MAP during CPB was relatively high (80-110 mmHg) than in the low pressure group (MAP 50-60 mmHg) (p = 0.026). For each of the individual outcomes the trend favored the high pressure group.

Therefore, MAP may be an important intraoperative therapeutic hemodynamic target to reduce the incidence of complications in patients undergoing CPB.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years old
• Signed informed consent
• Elective cardiac surgery under CPB (CABG or valve surgery)

Exclusion criteria

• Unstable Coronary Artery Disease: Recent (< 6 weeks) myocardial infarction, unstable angina, severe (> 70%) left main coronary artery stenosis
• Uncontrolled hypertension preoperatively (SBP > 160 mm Hg)
• Critical preoperative state (ventricular tachycardia or ventricular fibrillation or aborted sudden death, preoperative cardiac massage, preoperative ventilation before anesthetic room, hemodynamic instability, preoperative inotropes or intraaortic balloon pumping, preoperative severe acute renal failure (anuria or oliguria <10ml/hr)
• Planned surgery on aorta
• Emergency surgery
• Pregnancy
• Current enrollment into another randomized controlled trial (in the last 30 days)
• Previous enrollment and randomization into current study
• Glomerular filtration rate ≤59 ml/min/1.73m2 (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Individualized BP group

Experimental group

Description:

Individualized intraoperative BP management

Treatment:

Other: Individualized intraoperative BP management

Standard treatment group

Placebo Comparator group

Description:

Standard intraoperative BP management

Treatment:

Other: Standard intraoperative BP management