Targeted Blood-pressure Management and Acute Kidney Injury After Coronary Artery Bypass Surgery
NCT ID: NCT03629418
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
612 participants
INTERVENTIONAL
2018-08-14
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Targeted blood-pressure management
Prophylactic norepinephrine infusion is started at the beginning of anesthetic induction and maintained throughout surgery. The target is to maintain systolic blood pressure at 110 mmHg or higher during surgery.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo off-pump CABG surgery.
Exclusion Criteria
* 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.
50 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Beijing University First Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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, Persoon S, Peelen LM, Moons KG, Kalkman CJ, Kappelle LJ, van Klei WA. Intraoperative hypotension and perioperative ischemic stroke after general surgery: a nested case-control study. Anesthesiology. 2012 Mar;116(3):658-64. doi: 10.1097/ALN.0b013e3182472320.
Rettig TCD, Peelen LM, Geuzebroek GSC, van Klei WA, Boer C, van der Veer JW, Hofland J, van de Garde EMW, Noordzij PG. Impact of Intraoperative Hypotension During Cardiopulmonary Bypass on Acute Kidney Injury After Coronary Artery Bypass Grafting. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):522-528. doi: 10.1053/j.jvca.2016.07.040. Epub 2016 Jul 30.
Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.
Hiltebrand LB, Koepfli E, Kimberger O, Sigurdsson GH, Brandt S. Hypotension during fluid-restricted abdominal surgery: effects of norepinephrine treatment on regional and microcirculatory blood flow in the intestinal tract. Anesthesiology. 2011 Mar;114(3):557-64. doi: 10.1097/ALN.0b013e31820bfc81.
Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
Boettger S, Nunez DG, Meyer R, Richter A, Fernandez SF, Rudiger A, Schubert M, Jenewein J. Delirium in the intensive care setting and the Richmond Agitation and Sedation Scale (RASS): Drowsiness increases the risk and is subthreshold for delirium. J Psychosom Res. 2017 Dec;103:133-139. doi: 10.1016/j.jpsychores.2017.09.011. Epub 2017 Oct 4.
Chanques G, Garnier O, Carr J, Conseil M, de Jong A, Rowan CM, Ely EW, Jaber S. The CAM-ICU has now a French "official" version. The translation process of the 2014 updated Complete Training Manual of the Confusion Assessment Method for the Intensive Care Unit in French (CAM-ICU.fr). Anaesth Crit Care Pain Med. 2017 Oct;36(5):297-300. doi: 10.1016/j.accpm.2017.02.003. Epub 2017 Mar 29.
Katayama H, Kurokawa Y, Nakamura K, Ito H, Kanemitsu Y, Masuda N, Tsubosa Y, Satoh T, Yokomizo A, Fukuda H, Sasako M. Extended Clavien-Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria. Surg Today. 2016 Jun;46(6):668-85. doi: 10.1007/s00595-015-1236-x. Epub 2015 Aug 20.
Other Identifiers
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2018-118
Identifier Type: -
Identifier Source: org_study_id
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