Targeted Blood-pressure Management and Acute Kidney Injury After Coronary Artery Bypass Surgery

Официальное название

Impact of Targeted Blood-pressure Management on Incidence of Acute Kidney Injury After Off-pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial

Обзор

Acute renal injury (AKI) is a common complication after cardiac surgery and is associated with worse outcomes. It is now realized that intraoperative hypotension is an important risk factor for the development of AKI. In a recent randomized controlled trial of patients undergoing major noncardiac surgery, intraoperative individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. The investigators hypothesize that, for patients undergoing off-pump CABG, targeted blood-pressure management during surgery may also reduce the incidence of postoperative AKI.

Подробное описание

Acute renal injury (AKI) is a common complication after cardiac surgery. In patients undergoing noncardiac surgery, intraoperative hypotension may lead to hypoperfusion of important organs and result in organ injuries such as AKI, myocardial injury, and stroke. The development of organ injuries is associated with wose outcomes including higher 30-day or even 1-year mortality. In a recent randomized controlled trial, patients undergoing major noncardiac surgery received either individualized (systolic blood pressure \[SBP\] maintained within 10% of the reference level) or standard (SBP maintained above 80 mmHg or within 40% of the reference level) blood-pressure management strategy during surgery. The results showed that individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. Intraoperative hypotension is very common during off-pump coronary artery bypass grafting (CABG) surgery. The investigators hypothesize that, for patients undergoing off-pump CABG, good blood-pressure management with norepinephrine may also reduce the incidence of postoperative AKI. The purpose of this study is to investigate the effect of targeted blood-pressure management during off-pump CABG surgery on the incidence of postoperative AKI.

Вмешательства

• Препарат Targeted blood-pressure management
  Prophylactic norepinephrine infusion is started before anesthetic induction and maintained throughout surgery. The target is to maintain systolic blood pressure at 110 mmHg or higher.
• Препарат Routine blood-pressure management
  Phenylephrine (25-50 ug) is injected or vasopressors is infused only when necessary. The target is to maintain systolic blood pressure at 90 mmHg or higher during surgery.

Первичные конечные точки

• Incidence of acute kidney injury (AKI) within 7 days after surgery [Срок оценки: Up to 7 days after surgery]

Вторичные конечные точки (12)

• Classification of AKI within 7 days after surgery [Срок оценки: Up to 7 days after surgery]
• Incidence of delirium within 7 days after surgery [Срок оценки: Up to 7 days after surgery]
• Duration of mechanical ventilation after surgery [Срок оценки: Up to 30 days after surgery]
• Length of stay in intensive care unit (ICU) after surgery [Срок оценки: Up to 30 days after surgery]
• Length of stay in hospital after surgery [Срок оценки: Up to 30 days after surgery]
• Incidence of major adverse cardiovascular events (MACEs) within 30 days after surgery [Срок оценки: Up to 30 days after surgery]
• Incidence of non-MACE complications within 30 days after surgery [Срок оценки: Up to 30 days after surgery]
• All-cause 30-day mortality [Срок оценки: At 30 days after surgery]
• 2-year overall survival after surgery [Срок оценки: Up to 2 years after surgery]
• 2-year major adverse cardiovascular event (MACE)-free survival after surgery [Срок оценки: Up to 2 years after surgery]
• Cognitive function in 1- and 2-year survivors [Срок оценки: At the end of the 1st and 2nd years after surgery]
• Quality of life in 1- and 2- year survivors: SF-36 [Срок оценки: At the end of the 1st and 2nd years after surgery]

Критерии участия

Критерии включения

• Age ≥ 50 years;
• Scheduled to undergo off-pump CABG surgery.

Критерии исключения

• Refuse to participate;
• Untreated or uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
• Chronic kidney disease with a glomerular filtration rate < 30 ml/min/1.73 m2 or end-stage renal disease requiring renal-replacement therapy;
• Inability to communicate during the preoperative period because of coma, profound dementia, language barrier, or end-stage disease;
• Requirement of vasopressors/inotropics to maintain blood pressure before surgery;
• Second or emergency surgery;
• Expected survival of less than 24 hours.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Beijing University First Hospital — Пекин

Публикации

• Abelha FJ, Botelho M, Fernandes V, Barros H. Determinants of postoperative acute kidney injury. Crit Care. 2009;13(3):R79. doi: 10.1186/cc7894. Epub 2009 May 22. PMID 19463152
• 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. PMID 19934864
• Coca SG, Peixoto AJ, Garg AX, Krumholz HM, Parikh CR. The prognostic importance of a small acute decrement in kidney function in hospitalized patients: a systematic review and meta-analysis. Am J Kidney Dis. 2007 Nov;50(5):712-20. doi: 10.1053/j.ajkd.2007.07.018. PMID 17954284
• 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. PMID 15616043
• Schopka S, Diez C, Camboni D, Floerchinger B, Schmid C, Hilker M. Impact of cardiopulmonary bypass on acute kidney injury following coronary artery bypass grafting: a matched pair analysis. J Cardiothorac Surg. 2014 Jan 18;9:20. doi: 10.1186/1749-8090-9-20. PMID 24438155
• Rosner MH, Okusa MD. Acute kidney injury associated with cardiac surgery. Clin J Am Soc Nephrol. 2006 Jan;1(1):19-32. doi: 10.2215/CJN.00240605. Epub 2005 Oct 19. PMID 17699187
• Kheterpal S, Tremper KK, Heung M, Rosenberg AL, Englesbe M, Shanks AM, Campbell DA Jr. Development and validation of an acute kidney injury risk index for patients undergoing general surgery: results from a national data set. Anesthesiology. 2009 Mar;110(3):505-15. doi: 10.1097/ALN.0b013e3181979440. PMID 19212261
• 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. PMID 23835589

Идентификаторы

NCT: NCT03629418 · 2018-118

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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