Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery
- Conditions
- Cardiac Surgery
- Interventions
- Other: Standard intraoperative BP managementOther: Individualized intraoperative BP management
- Registration Number
- NCT03784690
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Brief Summary
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).
- Detailed 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- ≥18 years old
- Signed informed consent
- Elective cardiac surgery under CPB (CABG or valve surgery)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard treatment group Standard intraoperative BP management Standard intraoperative BP management Individualized BP group Individualized intraoperative BP management Individualized intraoperative BP management
- Primary Outcome Measures
Name Time Method Compliance with the protocol Operative day 1 Successful compliance with protocol is defined as ≥ 90% of prescribed intervention being administered across all patients.
Successful recruitment rate 12 month Successful recruitment rate will be defined as recruitment of 2 patients per week.
- Secondary Outcome Measures
Name Time Method Cerebral oxygenation (near infrared spectroscopy) Operative day1 Number of cerebral desaturations will be recorded intraoperatively.
Ventilation > 24 hours 30 days after surgery Number of patients with duration of ventilation more than 24 h.
Duration of ICU stay and hospitalization 30 days after surgery Number of postoperative days spent in the ICU and in the hospital will be counted.
30-day all-cause mortality 30 days after surgery Number of patients who will die within 30-day after surgery from any cause
Need for blood transfusions 30 days after surgery Number of patients who will need transfusions of any blood products (RBC, fresh frozen plasma, platelets, cryoprecipitate).
Peak concentration of lactate during CPB and up to 24 hours after surgery Postoperative day 1 Lactate values (mmol/l) will be measured every 6 hours during the first 24 postoperative hours.
Oxygen delivery during CPB Operative day 1 Oxygen delivery during CPB will be calculated according to the standard formula (pump flow x O2 arterial content).
Postoperative blood loss Postoperative day 1 Drainage volume (ml/kg) will be measured in the next morning after surgery.
Daily Sequential Organ Failure Assessment (SOFA) score 30 days after surgery Organ failure will be assessed by using Sequential Organ Failure Assessment (SOFA) score which will be recorded daily until patient discharge from the ICU. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The score ranges from 0 to 24 points (the higher the score, the higher the mortality).
Postoperative creatinine concentration 3 days after surgery Plasma creatinine level will be measured daily during 3 postoperative days.
Postoperative cardiac troponin I level 12 hours after surgery Cardiac troponin I level wil be measured in the time frame from 6 to 12 hours postoperatively.
Intraoperative blood pressure Operative day 1 Intraoperative blood pressure (mean, systolic and diastolic) will be registered every 5 minutes intraoperatively using invasive blood pressure monitoring system.
Rate of postoperative complications 30 days after surgery 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.
Trial Locations
- Locations (1)
Meshalkin Research Institute of Pathology of Circulation
🇷🇺Novosibirsk, Russian Federation