NCT06952387

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

Effect of Personalized Blood Pressure Management on Postoperative Complications and Mortality in High-risk Patients Undergoing Major Non-cardiac Surgery: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,624 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Anesthesia- and surgery-related complications and mortality constitute a critical global public health burden. Annually, over 300 million surgical procedures are performed worldwide, with postoperative complications and mortality standing as predominant contributors to adverse outcomes. 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. Refinement of perioperative management protocols-especially precision-guided hemodynamic control-has emerged as a pivotal strategy for optimizing patient prognosis. Intraoperative hypotension (IOH), a pervasive clinical phenomenon affecting 40%-90% of surgical cases, is conventionally defined through either absolute thresholds (e.g., systolic blood pressure (SBP) \<90 mmHg or mean arterial pressure (MAP) \<65 mmHg) or relative reductions from baseline values (\>20% decline). Its high prevalence and association with end-organ hypoperfusion have positioned IOH as a central concern in perioperative care. 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: Current paradigms predominantly apply population-based fixed thresholds (e.g., MAP ≥75-80 mmHg vs. ≥60 mmHg), disregarding interindividual hemodynamic variability. Although The Intraoperative Norepinephrine to Control Arterial Pressure (INPRESS) study used personalized blood pressure targets, its approach of measuring baseline blood pressure during a single clinic visit conflicts with current evidence. Research shows that 24-hour ambulatory monitoring is the most reliable method to capture an individual's true baseline blood pressure and daily fluctuations. 2. Therapeutic strategy limitations: Conventional protocols emphasizing aggressive vasopressor use to achieve arbitrary pressure targets may inadvertently increase complications like anastomotic leakage and AKI. Furthermore, the multifactorial etiology of IOH-encompassing hypovolemia, vasoplegia, and impaired cardiac contractility-demands etiology-specific management algorithms rather than universal interventions. In light of current evidence, perioperative hypotension management demands personalized strategies. To address this need, the investigators propose a multicenter randomized controlled trial (RCT) that pioneers the integration of ambulatory blood pressure monitoring (ABPM) with etiology-specific intervention protocols. This study aims to clarify the clinical benefits of individualized blood pressure management and establish high-quality evidence to advance precision anesthesia practices in perioperative care.

Conditions

• Hypotension

Interventions

Type	Name	Description
OTHER	Personalized blood pressure management	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.
OTHER	Routine blood pressure management	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.

Timeline

• Start date: 2025-06-03
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-04-30
• Last updated: 2025-07-14

Locations

7 sites across 1 country: China