PeRsonalized Blood prEssure Management on Postoperative Complications and Mortality in hIgh-risk Patients Undergoing Major Non-cardiac Surgery

NCT06952387 | Recruiting DMC

• 1 other identifier: NFEC-2025-134
• Study Type: interventional
• Target: 1,624
• Locations: 1 country
• Sites: 7

Brief Summary

High-risk populations, particularly elderly individuals and patients with cardiovascular comorbidities, exhibit markedly elevated incidences of postoperative myocardial injury (MINS), acute kidney injury (AKI), and mortality. Intraoperative hypotension (IOH), a pervasive clinical phenomenon affecting 40%-90% of surgical cases, Substantial observational evidence links IOH severity/duration to ischemic organ injuries (MINS, AKI) and long-term morbidity.Nevertheless, inherent limitations of observational designs-particularly residual confounding-preclude definitive causal inferences. Notably, randomized controlled trials (RCTs) investigating goal-directed hemodynamic interventions demonstrate inconsistent clinical benefits, underscoring the imperative to clarify causal mechanisms between IOH and organ injury. This causal ambiguity arises from two unresolved scientific questions: (1) Threshold personalization deficit; (2) Therapeutic strategy limitations. In light of current evidence, perioperative hypotension management demands personalized strategies, the investigators propose a multicenter randomized controlled trial (RCT) that aims to clarify the clinical benefits of individualized blood pressure management.

Conditions

Hypotension

Keywords

Blood Pressure; Postoperative complications; Mortality; Non-cardiac surgery

Outcome Measures

Primary Outcomes (1)

• A composite of postoperative complications and mortality within 30 days after surgery

  Defined as a composite of myocardial injury after non-cardiac surgery (MINS), myocardial infarction (MI), postoperative acute heart failure, non-fatal cardiac arrest, stroke, acute kidney injury (AKI), all-cause mortality.

  Up to 30 days after surgery

Secondary Outcomes (7)

• The individual components of the primary composite outcome within 30 days after surgery

  Up to 30 days after surgery

• Proportion of ICU admission after surgery

  Up to 30 days after surgery

• Length of stay in ICU after surgery

  Up to 30 days after surgery

• Length of stay in the hospital after surgery

  Up to 30 days after surgery

• Other major postoperative complications within 30 days after surgery

  Up to 30 days after surgery

Other Outcomes (5)

• Overall survival after surgery

  Up to 1 year after surgery

• Disability at 6 months after surgery

  At 6 months after surgery

• Disability at 1 year after surgery

  At 1 year after surgery

Study Arms (2)

Control group

OTHER

In patients assigned to control group, clinicians were unaware of the results of preoperative automated 24-h blood pressure monitoring and thus managed blood pressure per institutional routine which generally is to maintain MAP above 60 mmHg. Routine blood pressure management started with the induction of anesthesia and lasted for 2 hours after surgery.

Other: Routine blood pressure management

Intervention group

EXPERIMENTAL

In patients assigned to intervention group, clinicians were asked to maintain intraoperative MAP above the preoperative baseline MAP (with a maximum MAP target of 110 mmHg and a minimum MAP target of 65mmHg). Personalized blood pressure management started with the induction of anesthesia and lasted for 2 hours after surgery.

Other: Personalized blood pressure management

Interventions

Personalized blood pressure management OTHER

In patients assigned to personalized blood pressure management, clinicians were asked to maintain intraoperative MAP at least at the preoperative mean 24-hour MAP (with a maximum MAP target of 110 mmHg) from anesthesia induction to 2 hors after completion of surgery. If the preoperative mean 24-hour MAP was below 65mmHg, intraoperative MAP was maintained at least at 65mmHg. The mini fluid challenge (mini-FC, 100ml fluid infusion within 1minute) will be used to assess fluid responsiveness. A positive min-FC response (a stroke volume (SV) increase of at least 5%) will trigger fluid challenge (FC) administration (4ml/kg of balanced crystalloid or colloid within 10 minutes), whereas a negative min-FC response will trigger vasoactive drug administration.

Also known as: Individualized blood pressure management

Intervention group

Routine blood pressure management OTHER

In patients assigned to routine blood pressure management, clinicians were blinded to the results of preoperative automated 24-hour blood pressure monitoring, and thus managed blood pressure per institutional routine which generally is to maintain MAP above 60 mmHg. The mini fluid challenge (mini-FC, 100ml fluid infusion within 1minute) will be used to assess fluid responsiveness. A positive min-FC response (a stroke volume (SV) increase of at least 5%) will trigger FC administration (4ml/kg of balanced crystalloid or colloid within 10 minutes), whereas a negative min-FC response will trigger vasoactive drug administration.

Also known as: Standard blood pressure management

Control group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65-90 yr;
• Scheduled to undergo elective non-cardiac major surgery under general anesthesia (with an estimated surgery duration of ≥ 2 hours and an anticipated postoperative hospital stay of ≥ 2 days);
• Patients with high cardiovascular risk, meeting at least one of the following conditions:
• History of stroke;
• History of coronary artery disease;
• History of congestive heart failure;
• History of peripheral arterial disease;
• Preoperative brain natriuretic peptide (BNP) ≥ 92 mg/L or N-terminal pro-brain natriuretic peptide (NT-proBNP) ≥ 300 ng/L;
• Preoperative cardiac troponin (cTn) or high-sensitivity cardiac troponin (hs-cTn) \> upper reference limit;
• Hypertension requiring medication treatment;
• Diabetes requiring medication treatment;
• History of chronic kidney disease;
• Continuous smoking for 2 years or more, with interruptions of less than one month before the current hospital admission;
• Hypercholesterolemia;
• History of transient ischemic attack.

You may not qualify if:

• Refuse to participate this trial;
• Inability to communicate in the preoperative period because of coma, profound dementia, or language barrier;
• Severe uncontrolled hypertension before surgery (systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 110 mmHg);
• Severe hepatic dysfunction (Child-Pugh Class C); or severe renal dysfunction required preoperative dialysis; or American Society of Anesthesiologists (ASA) physical status ≥ V; or expectation lifespan ≤ 24h;
• Unstable cardiovascular conditions: acute coronary syndrome, decompensated heart failure, severe arrhythmias, severe valvular heart disease;
• Scheduled to undergo neurosurgical procedures, transplantation, vascular surgery;
• Urgent surgery;
• Diagnosed with sepsis or sepsis shock before surgery.
• Requiring vasopressor treatment before surgery.
• Unable to finish 24-hour automated blood pressure monitor;
• Current participation in another interventional study.
• Any condition deemed ineligible for participation by clinicians.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (7)

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

ACTIVE NOT RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

The Affiliated Panyu Central Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 511431, China

RECRUITING

The Third People's Hospital of Shenzhen

Shenzhen, Guangdong, 518112, China

NOT YET RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

NOT YET RECRUITING

Related Publications (7)

• Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.

  PMID: 30236233 BACKGROUND

• Saugel B, Fletcher N, Gan TJ, Grocott MPW, Myles PS, Sessler DI; PeriOperative Quality Initiative XI (POQI XI) Workgroup Members. PeriOperative Quality Initiative (POQI) international consensus statement on perioperative arterial pressure management. Br J Anaesth. 2024 Aug;133(2):264-276. doi: 10.1016/j.bja.2024.04.046. Epub 2024 Jun 4.

  PMID: 38839472 BACKGROUND

• Wanner PM, Wulff DU, Djurdjevic M, Korte W, Schnider TW, Filipovic M. Targeting Higher Intraoperative Blood Pressures Does Not Reduce Adverse Cardiovascular Events Following Noncardiac Surgery. J Am Coll Cardiol. 2021 Nov 2;78(18):1753-1764. doi: 10.1016/j.jacc.2021.08.048.

  PMID: 34711333 BACKGROUND

• Marcucci M, Painter TW, Conen D, Lomivorotov V, Sessler DI, Chan MTV, Borges FK, Leslie K, Duceppe E, Martinez-Zapata MJ, Wang CY, Xavier D, Ofori SN, Wang MK, Efremov S, Landoni G, Kleinlugtenbelt YV, Szczeklik W, Schmartz D, Garg AX, Short TG, Wittmann M, Meyhoff CS, Amir M, Torres D, Patel A, Ruetzler K, Parlow JL, Tandon V, Fleischmann E, Polanczyk CA, Lamy A, Jayaram R, Astrakov SV, Wu WKK, Cheong CC, Ayad S, Kirov M, de Nadal M, Likhvantsev VV, Paniagua P, Aguado HJ, Maheshwari K, Whitlock RP, McGillion MH, Vincent J, Copland I, Balasubramanian K, Biccard BM, Srinathan S, Ismoilov S, Pettit S, Stillo D, Kurz A, Belley-Cote EP, Spence J, McIntyre WF, Bangdiwala SI, Guyatt G, Yusuf S, Devereaux PJ; POISE-3 Trial Investigators and Study Groups. Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery : An International Randomized Controlled Trial. Ann Intern Med. 2023 May;176(5):605-614. doi: 10.7326/M22-3157. Epub 2023 Apr 25.

  PMID: 37094336 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

• Nicklas JY, Bergholz A, Dake F, Pham HHD, Rabe MC, Schlichting H, Skrovanek S, Flick M, Kouz K, Fischer M, Olotu C, Izbicki JR, Mann O, Fisch M, Schmalfeldt B, Frosch KH, Renne T, Krause L, Zollner C, Saugel B. Personalised blood pressure management during major noncardiac surgery and postoperative neurocognitive disorders: a randomised trial. BJA Open. 2024 Jul 1;11:100294. doi: 10.1016/j.bjao.2024.100294. eCollection 2024 Sep.

  PMID: 39050403 BACKGROUND

• Saugel B, Reese PC, Sessler DI, Burfeindt C, Nicklas JY, Pinnschmidt HO, Reuter DA, Sudfeld S. Automated Ambulatory Blood Pressure Measurements and Intraoperative Hypotension in Patients Having Noncardiac Surgery with General Anesthesia: A Prospective Observational Study. Anesthesiology. 2019 Jul;131(1):74-83. doi: 10.1097/ALN.0000000000002703.

  PMID: 30998509 BACKGROUND

MeSH Terms

Conditions

Hypotension; Postoperative Complications

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ke-Xuan Liu, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Xuan Liu, MD

CONTACT

13710684096; liukexuan705@163.com

Shuang-Jie Cao, MD

CONTACT

13651119431; caosjie1994@126.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: SPONSOR

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 30, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)