Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery
關鍵詞
抽象
描述
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.
日期
| 最後驗證: | 10/31/2019 |
| 首次提交: | 10/02/2018 |
| 提交的預估入學人數: | 12/20/2018 |
| 首次發布: | 12/23/2018 |
| 上次提交的更新: | 11/19/2019 |
| 最近更新發布: | 11/21/2019 |
| 實際學習開始日期: | 01/20/2019 |
| 預計主要完成日期: | 03/09/2020 |
| 預計完成日期: | 04/09/2020 |
狀況或疾病
干預/治療
Other: Individualized BP group
Other: Standard treatment group
相
手臂組
| 臂 | 干預/治療 |
|---|---|
| Experimental: Individualized BP group Individualized intraoperative BP management | Other: Individualized BP group 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. |
| Placebo Comparator: Standard treatment group Standard intraoperative BP management | Other: Standard treatment group 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. |
資格標準
| 有資格學習的年齡 | 18 Years 至 18 Years |
| 有資格學習的性別 | All |
| 接受健康志願者 | 是 |
| 標準 | 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) |
結果
主要結果指標
1. Compliance with the protocol [Operative day 1]
2. Successful recruitment rate [12 month]
次要成果指標
1. Postoperative creatinine concentration [3 days after surgery]
2. Postoperative cardiac troponin I level [12 hours after surgery]
3. Intraoperative blood pressure [Operative day 1]
4. Rate of postoperative complications [30 days after surgery]
5. Postoperative blood loss [Postoperative day 1]
6. Daily Sequential Organ Failure Assessment (SOFA) score [30 days after surgery]
7. Peak concentration of lactate during CPB and up to 24 hours after surgery [Postoperative day 1]
8. Oxygen delivery during CPB [Operative day 1]
9. Cerebral oxygenation (near infrared spectroscopy) [Operative day1]
10. Ventilation > 24 hours [30 days after surgery]
11. Duration of ICU stay and hospitalization [30 days after surgery]
12. 30-day all-cause mortality [30 days after surgery]
13. Need for blood transfusions [30 days after surgery]
