HypotensionPREMIUMNCT06952387
PeRsonalized Blood prEssure Management on Postoperative Complications and Mortality in hIgh-risk Patients Undergoing Major Non-cardiac Surgery
A study testing Personalized blood pressure management and Routine blood pressure management in people with Hypotension, run by Nanfang Hospital, Southern Medical University at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Hypotension
- What is being tested?
- Personalized blood pressure management and Routine blood pressure management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,624 participants
- Where
- 7 sitesChina
- Study dates
- 3 Jun 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
Show all 15Show fewer
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 6 recruiting
- Active, not recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Ke-Xuan Liu, MD, 13710684096, liukexuan705@163.com
- Recruiting
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 511431
Zhong-Xian He
- Not yet recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Gang Chen
- Not yet recruiting
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, 518112
Qiang Wu, MD
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Wei Gao, MD
- Not yet recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
De-Zhao Liu, MD
About this study
Official title: Effect of Personalized Blood Pressure Management on Postoperative Complications and Mortality in High-risk Patients Undergoing Major Non-cardiac Surgery: a Randomized Controlled Trial
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.
Read the 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:
- 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.
- 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
- Being tested
- Personalized blood pressure management, Routine blood pressure management
- Keywords
- Blood Pressure, Postoperative complications, Mortality, Non-cardiac surgery
- Medical subject headings
- Hypotension, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized blood pressure managementOther
Also called Individualized 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.
Routine blood pressure managementOther
Also called Standard 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Personalized blood pressure management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days after surgery
Secondary outcomes (7)
The individual components of the primary composite outcome within 30 days after surgery
The incidence of individual components of the primary composite outcome (MINS, MI, postoperative acute heart failure, non-fatal cardiac arrest, stroke, AKI and all-cause mortality).
Measured: Up to 30 days after surgery
Proportion of ICU admission after surgery
Proportion of patients admitted in intensive care unit after surgery.
Measured: Up to 30 days after surgery
Length of stay in ICU after surgery
For patients admitted to ICU after surgery, the investigators record the length of stay in the unit.
Measured: Up to 30 days after surgery
Length of stay in the hospital after surgery
Length of stay in the hospital after surgery.
Measured: Up to 30 days after surgery
Other major postoperative complications within 30 days after surgery
Defined as new onset medical events other than primary composite outcome that were deemed harmful and required therapeutic intervention, that is, Grade II or higher on the Clavien-Dindo classification.
Measured: Up to 30 days after surgery
Time to first oral intake after surgery
Defined as the time interval from surgery completion to first oral intake.
Measured: Up to 30 days after surgery
Time to first flatus passage after surgery
Defined as the time interval from surgery completion to first flatus passage
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start3 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ke-Xuan Liu, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952387
- Sponsor's protocol ID
- NFEC-2025-134
- Acronym
- PREMIUM
- Status last verified
- Jul 2025
- First submitted
- 20 Apr 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30236233Saugel 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.
PubMed 38839472Wanner 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.
PubMed 34711333Marcucci 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.
PubMed 37094336Futier 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.
PubMed 28973220Nicklas 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.
PubMed 39050403Saugel 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.
PubMed 30998509
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Personalized Blood Pressure Management on Postoperative Complications and Mortality in High-risk Patients Undergoing Major Non-cardiac Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06952387
- Acronym / sponsor ID
- PREMIUM / NFEC-2025-134
- Conditions
- Hypotension
- Keywords
- Blood Pressure, Postoperative complications, Mortality, Non-cardiac surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,624 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Routine blood pressure managementIn 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. |
| Intervention group | Experimental | Other: Personalized blood pressure managementIn 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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized blood pressure managementAlso: Individualized blood pressure managementIn 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 | Intervention group |
| Routine blood pressure managementAlso: Standard blood pressure managementIn 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. | Other | Control group |
Primary outcome
A composite of postoperative complications and mortality within 30 days after surgery
Time frame: Up to 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.
7 secondary outcomes
The individual components of the primary composite outcome within 30 days after surgery
Time frame: Up to 30 days after surgery
Proportion of ICU admission after surgery
Time frame: Up to 30 days after surgery
Length of stay in ICU after surgery
Time frame: Up to 30 days after surgery
Length of stay in the hospital after surgery
Time frame: Up to 30 days after surgery
Other major postoperative complications within 30 days after surgery
Time frame: Up to 30 days after surgery
Time to first oral intake after surgery
Time frame: Up to 30 days after surgery
Time to first flatus passage after surgery
Time frame: Up to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 30236233Wesselink 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.
- Background: PubMed 38839472Saugel 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.
- Background: PubMed 34711333Wanner 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.
- Background: PubMed 37094336Marcucci 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.
- Background: PubMed 28973220Futier 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.
- Background: PubMed 39050403Nicklas 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.
- Background: PubMed 30998509Saugel 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.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ke-Xuan Liu, MD principal investigator
Nanfang Hospital, Southern Medical University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized blood pressure management and Routine blood pressure management in people with Hypotension, run by Nanfang Hospital, Southern Medical University at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke-Xuan Liu, MD (13710684096, liukexuan705@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of postoperative complications and mortality within 30 days after surgery (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06952387, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.