Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery. A Pilot, Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- Compliance with the protocol
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Compliance with the protocol
Time Frame: Operative day 1
Successful compliance with protocol is defined as ≥ 90% of prescribed intervention being administered across all patients.
Successful recruitment rate
Time Frame: 12 month
Successful recruitment rate will be defined as recruitment of 2 patients per week.
Secondary Outcomes
- Postoperative blood loss(Postoperative day 1)
- Daily Sequential Organ Failure Assessment (SOFA) score(30 days after surgery)
- Postoperative creatinine concentration(3 days after surgery)
- Postoperative cardiac troponin I level(12 hours after surgery)
- Intraoperative blood pressure(Operative day 1)
- Rate of postoperative complications(30 days after surgery)
- Cerebral oxygenation (near infrared spectroscopy)(Operative day1)
- Ventilation > 24 hours(30 days after surgery)
- Duration of ICU stay and hospitalization(30 days after surgery)
- 30-day all-cause mortality(30 days after surgery)
- Need for blood transfusions(30 days after surgery)
- Peak concentration of lactate during CPB and up to 24 hours after surgery(Postoperative day 1)
- Oxygen delivery during CPB(Operative day 1)