Clinical trial NCT03784690: Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery
Official title: Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery. A Pilot, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiac Surgery
Keywords: Hypotension
Intraoperative blood pressure
Cardiopulmonary bypass
Myocardial infarction
Acute kidney injury
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2018-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Compliance with the protocol
timeFrame: Operative day 1
measure: Successful recruitment rate
timeFrame: 12 month
Secondary outcomes:
measure: Postoperative creatinine concentration
timeFrame: 3 days after surgery
measure: Postoperative cardiac troponin I level
timeFrame: 12 hours after surgery
measure: Intraoperative blood pressure
timeFrame: Operative day 1
measure: Rate of postoperative complications
timeFrame: 30 days after surgery
measure: Postoperative blood loss
timeFrame: Postoperative day 1
measure: Daily Sequential Organ Failure Assessment (SOFA) score
timeFrame: 30 days after surgery
measure: Peak concentration of lactate during CPB and up to 24 hours after surgery
timeFrame: Postoperative day 1
measure: Oxygen delivery during CPB
timeFrame: Operative day 1
measure: Cerebral oxygenation (near infrared spectroscopy)
timeFrame: Operative day1
measure: Ventilation > 24 hours
timeFrame: 30 days after surgery
measure: Duration of ICU stay and hospitalization
timeFrame: 30 days after surgery
measure: 30-day all-cause mortality
timeFrame: 30 days after surgery
measure: Need for blood transfusions
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Meshalkin Research Institute of Pathology of Circulation
Study officials:
affiliation: Meshalkin Research Institute of Pathology of Circulation
name: Vladimir Lomivorotov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sessler DI, Khanna AK. Perioperative myocardial injury and the contribution of hypotension. Intensive Care Med. 2018 Jun;44(6):811-822. doi: 10.1007/s00134-018-5224-7. Epub 2018 Jun 4.
citation: Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
citation: Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.
citation: Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.
citation: Sun LY, Chung AM, Farkouh ME, van Diepen S, Weinberger J, Bourke M, Ruel M. Defining an Intraoperative Hypotension Threshold in Association with Stroke in Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):440-447. doi: 10.1097/ALN.0000000000002298.
citation: Gold JP, Charlson ME, Williams-Russo P, Szatrowski TP, Peterson JC, Pirraglia PA, Hartman GS, Yao FS, Hollenberg JP, Barbut D, et al. Improvement of outcomes after coronary artery bypass. A randomized trial comparing intraoperative high versus low mean arterial pressure. J Thorac Cardiovasc Surg. 1995 Nov;110(5):1302-11; discussion 1311-4. doi: 10.1016/S0022-5223(95)70053-6.