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

NCT03629418 | Recruiting DMC

• 1 other identifier: 2018-118
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Bypass, Off-Pump; Intraoperative Hypotension; Acute Kidney Injury; Preventive Medicine; Intraoperative Care

Keywords

Coronary Artery Bypass, Off-Pump; Intraoperative Hypotension; Acute Kidney Injury; Preventive Medicine; Intraoperative Care

Outcome Measures

Primary Outcomes (1)

• Incidence of acute kidney injury (AKI) within 7 days after surgery

  Development of AKI within 7 days after surgery is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria

  Up to 7 days after surgery

Secondary Outcomes (12)

• Classification of AKI within 7 days after surgery

  Up to 7 days after surgery

• Incidence of delirium within 7 days after surgery

  Up to 7 days after surgery

• Duration of mechanical ventilation after surgery

  Up to 30 days after surgery

• Length of stay in intensive care unit (ICU) after surgery

  Up to 30 days after surgery

• Length of stay in hospital after surgery

  Up to 30 days after surgery

Other Outcomes (3)

• Pain severity within 3 days after surgery: NRS

  Up to 3 days after surgery

• Daily prevalence of delirium during postoperative days 1-7

  During the first 7 days after surgery

• Duration of intraoperative cerebral desaturation (sub-study)

  During surgery

Study Arms (2)

Targeted blood-pressure management

EXPERIMENTAL

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.

Drug: Targeted blood-pressure management

Routine blood-pressure management

ACTIVE COMPARATOR

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.

Drug: Routine blood-pressure management

Interventions

Targeted blood-pressure management DRUG

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.

Also known as: Norepinephrine

Targeted blood-pressure management

Routine blood-pressure management DRUG

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.

Also known as: Phenylephrine and other vasopressors

Routine blood-pressure management

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Beijing University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (16)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 22277949 BACKGROUND

• 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.

  PMID: 27727080 BACKGROUND

• 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.

  PMID: 10439777 BACKGROUND

• 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.

  PMID: 21307765 BACKGROUND

• 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.

  PMID: 28973220 BACKGROUND

• 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.

  PMID: 29167040 BACKGROUND

• 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.

  PMID: 28365244 BACKGROUND

• 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.

  PMID: 26289837 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Norepinephrine; Phenylephrine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

8610-83572784; wangdongxin@hotmail.com

Li Huang, MD, PhD

CONTACT

8610-83572460; huanglibd@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: August 14, 2018
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)