Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery

Meshalkin Research Institute of Pathology of Circulation

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Cardiac Surgery

Interventions

Individualized intraoperative BP managementOTHER

In the treatment group, the nurse will measure resting blood pressure three times in the ward one day before surgery (after a 5-min rest while lying supine). Average measurement will be used to calculate mean arterial pressure (MAP). Before and after CPB patients will receive continuous infusion of norepinephrine to maintain MAP within ± 10% of patients resting MAP. If targeted MAP during CPB could not be achieved after increasing pump-flow (not more than 130%), infusion of norepinephrine will used. After CPB, the choice of vasopressors/inotropes to maintain predefined MAP will be left on attending anesthesiologists based on patient status.

Standard intraoperative BP managementOTHER

Standard treatment strategy will be used aiming to maintain pre-bypass and post-bypass MAP at 65-75 mm Hg. MAP during CPB will be maintained at 50-60 mm Hg. If MAP of 50-60 mm Hg during CPB could not be achieved after increasing pump-flow (not more than 130%), infusion of norepinephrine will be started. No vasodilators will be used if MAP will exceed predefined range.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Meshalkin Research Institute of Pathology of Circulation

Novosibirsk, Russia

Outcomes

Primary Outcomes

Compliance with the protocol

Successful compliance with protocol is defined as ≥ 90% of prescribed intervention being administered across all patients.

Time frame: Operative day 1

Successful recruitment rate

Successful recruitment rate will be defined as recruitment of 2 patients per week.

Time frame: 12 month

Secondary Outcomes

Postoperative creatinine concentration

Plasma creatinine level will be measured daily during 3 postoperative days.

Time frame: 3 days after surgery

Postoperative cardiac troponin I level

Cardiac troponin I level wil be measured in the time frame from 6 to 12 hours postoperatively.

Time frame: 12 hours after surgery

Intraoperative blood pressure

Intraoperative blood pressure (mean, systolic and diastolic) will be registered every 5 minutes intraoperatively using invasive blood pressure monitoring system.

Time frame: Operative day 1

Rate of postoperative complications

Postoperative complications (myocardial infarction, atrial fibrillation, stroke, delirium, need for renal replacement therapy, infection, reexploration for bleeding) will be defined according to standard European Society of Anaesthesiology/European Society of Intensive Care Medicine definitions where possible.

Time frame: 30 days after surgery

Postoperative blood loss

Drainage volume (ml/kg) will be measured in the next morning after surgery.

Data from ClinicalTrials.gov

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