Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery (PRECISE)
Individualized Blood Pressure Management in Patients Undergoing Cardiac Surgery. A Pilot, Randomized Controlled Study
調査の概要
状態
条件
詳細な説明
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.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Novosibirsk、ロシア連邦、630055
- Meshalkin Research Institute of Pathology of Circulation
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Individualized BP group
Individualized intraoperative BP management
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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. |
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プラセボコンパレーター：Standard treatment group
Standard intraoperative BP management
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Compliance with the protocol
時間枠：Operative day 1
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Successful compliance with protocol is defined as ≥ 90% of prescribed intervention being administered across all patients.
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Operative day 1
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Successful recruitment rate
時間枠：12 month
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Successful recruitment rate will be defined as recruitment of 2 patients per week.
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12 month
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Postoperative creatinine concentration
時間枠：3 days after surgery
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Plasma creatinine level will be measured daily during 3 postoperative days.
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3 days after surgery
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Postoperative cardiac troponin I level
時間枠：12 hours after surgery
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Cardiac troponin I level wil be measured in the time frame from 6 to 12 hours postoperatively.
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12 hours after surgery
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Intraoperative blood pressure
時間枠：Operative day 1
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Intraoperative blood pressure (mean, systolic and diastolic) will be registered every 5 minutes intraoperatively using invasive blood pressure monitoring system.
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Operative day 1
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Rate of postoperative complications
時間枠：30 days after surgery
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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.
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30 days after surgery
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Postoperative blood loss
時間枠：Postoperative day 1
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Drainage volume (ml/kg) will be measured in the next morning after surgery.
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Postoperative day 1
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Daily Sequential Organ Failure Assessment (SOFA) score
時間枠：30 days after surgery
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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).
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30 days after surgery
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Peak concentration of lactate during CPB and up to 24 hours after surgery
時間枠：Postoperative day 1
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Lactate values (mmol/l) will be measured every 6 hours during the first 24 postoperative hours.
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Postoperative day 1
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Oxygen delivery during CPB
時間枠：Operative day 1
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Oxygen delivery during CPB will be calculated according to the standard formula (pump flow x O2 arterial content).
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Operative day 1
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Cerebral oxygenation (near infrared spectroscopy)
時間枠：Operative day1
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Number of cerebral desaturations will be recorded intraoperatively.
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Operative day1
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Ventilation > 24 hours
時間枠：30 days after surgery
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Number of patients with duration of ventilation more than 24 h.
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30 days after surgery
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Duration of ICU stay and hospitalization
時間枠：30 days after surgery
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Number of postoperative days spent in the ICU and in the hospital will be counted.
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30 days after surgery
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30-day all-cause mortality
時間枠：30 days after surgery
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Number of patients who will die within 30-day after surgery from any cause
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30 days after surgery
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Need for blood transfusions
時間枠：30 days after surgery
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Number of patients who will need transfusions of any blood products (RBC, fresh frozen plasma, platelets, cryoprecipitate).
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30 days after surgery
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協力者と研究者
捜査官
- 主任研究者：Vladimir Lomivorotov, MD, PhD、Meshalkin Research Institute of Pathology of Circulation
出版物と役立つリンク
一般刊行物
- 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. Erratum In: Anesthesiology. 2019 Feb;130(2):360.
- 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.
- 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.
- 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.
- 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.
- 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.
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研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
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最終確認日
詳しくは
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