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Intraoperative HypotensionNCT06909786

Hypotension Prediction Index and Intraoperative Hypotension Incidence

A study testing HPI guided hemodynamic management and standard arterial line in people with Intraoperative Hypotension, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aim to implement intraoperative hemodynamic monitoring and management guided with HPI algorithm in frail patients undergoing elective abdominal surgery. Investigators hypothesize that the use of this algorithm will alter treatment of hypotension and reduces the amount of hypotension as measured by the time… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Intraoperative Hypotension
What is being tested?
HPI guided hemodynamic management and standard arterial line
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteChina
Study dates
1 Apr 2025to 31 Dec 2025
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age> 60 years old
  • Frail score > 2
  • ASA≥2
  • Planned to receive general anesthesia
  • Elective laparoscopic or laparotomy major abdominal surgery with an expected duration of > 180 minutes
  • Planned to receive an arterial line monitoring intraoperatively
  • Being able to give written informed consent prior to surgery

Who cannot join

  • Severe cardiac arrhythmia including atrial fibrillation
  • Severe aortic stenosis
  • Uncontrolled Hypertension (sitting systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥100 mmHg during screening)
  • Significant hypotension before surgery defined as a MAP <65mmHg
  • Chronic kidney disease with glomerular filtration rate <30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease
  • Organ transplant surgery, surgery involving the kidney, liver surgery requiring hilar blockage, surgery requiring controlled hypotension or controlled low central venous pressure

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • the First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Zheng Guan, +8613572592715, guanzheng1980@126.com

    Guan

Other trials in China

About this study

Official title: Effect of Intraoperative Implementation of the Hypotension Prediction Index (HPI) Guided Management Strategy on Incidents of Intraoperative Hypotension Among Frail Patients Undergoing Major Abdominal Surgery

This study aim to implement intraoperative hemodynamic monitoring and management guided with HPI algorithm in frail patients undergoing elective abdominal surgery. Investigators hypothesize that the use of this algorithm will alter treatment of hypotension and reduces the amount of hypotension as measured by the time weighted average (TWA) during non-cardiac surgery and to anticipate a reduction of postoperative AKI incidents, to explore the clinical benefits of impact of Acumen guided algorithm hemodynamic management in postoperative intestinal function recovery, and postoperative cardiac complications.

Read the detailed description

Intraoperative hypotension (IOH) is common, a study involved 34,045 surgical patients in elective, emergency, and intensive care unit (ICU) found that the incidence of hypotension (defined as systolic blood pressure below 80mmHg) greater than 5 minutes and 10 minutes was 25.7% and 14.6%, respectively. In another large sample size study of 22,109 patients with ASA grade 3 to 4 undergoing surgery with duration of ≥180 minutes found that 88% of patients experienced at least one episode of intraoperative hypotension, defined as a fall in mean arterial pressure (MAP) below 65 mmHg lasting at least 1 min. A multicenter retrospective cohort study from the U.S. electronic health record database conducted between 2008 and 2017 and including 368222 noncardiac surgeries reported that the incidence of MAP ≤65 mmHg during surgery was 19.3%.

IOH was significantly associated with postoperative complications and poor outcomes. Meta-analysis suggests that IOH increases the incidence of acute kidney injury, myocardial injury, and 30-day mortality after noncardiac surgery. Intraoperative MAP below 70 mmHg is an independent risk factor for increased mortality at 30 days postoperatively, while intraoperative MAP below 65 mmHg is an independent risk factor for myocardial injury after noncardiac surgery. Studies of non-cardiac, non-obstetric surgery have found that intraoperative MAP events below 55 mmHg is associated with persistent renal impairment up to 90 days postoperatively. In addition, intraoperative MAP reductions of more than 30% are associated with postoperative ischemic stroke.

China is experiencing an aging population, the number of elderly patients receiving surgical anesthesia is increasing year by year. Based on the 5-items frailty assessment scale shown that old age is closely related to the development of frailty. The prevalence of frailty among patients over 65-year-old was 7%, and 26% in patients with age over 85 years. Frailty refers to a state in which the functions of multiple systems are cumulatively reduced, leading to a decline in the body's reserve capacity and resistance. Frail patients have decreased organ reserve function, decreased response ability to surgical stress, reduced cardiac stroke volume, impaired cardiac autonomic nervous system function, and decreased albumin levels, resulting in increased blood concentration of anesthetic drugs, at risk for persistent hypotension and severe postoperative complications. In addition, the occurrence of intraoperative hypotension may further aggravate organ dysfunction on the impaired functionality of ischemia-sensitive organs such as the kidneys. The postoperative complications in frail patients undergoing abdominal surgery is as high as 45.5-57.1%. Therefore, it is important to strengthen intraoperative blood pressure management and prevent hypotensive events in frail patients.

IOH is preventable and may potential to improvement in postoperative outcomes. Futier et al highlighted management targeting an individualized systolic blood pressure, compared with standard management, reduced the risk of postoperative organ dysfunction 30 days after surgery. Current treatment of intraoperative hypotensive episodes is not proactive and rather occurs with some delay. For elderly frail populations undergoing major surgery, there is need for a novel method to prevent hypotension.

Edwards Lifesciences has developed an algorithm that by applying machine learning methods analyzing continuously invasively measured arterial waveforms with the Acumen lQ is able to predict hypotension, defined as a mean arterial pressure (MAP) below 65 mmHg lasting for at least 1 min. The Hypotension Prediction Index (HPI) ranges from 0 to 100, and higher values reflect a higher likelihood of hypotension and shorter intervals between periods of hypotension. In major abdominal surgery, HPI demonstrated a sensitivity of 85.8%, 81.7%, and 80.6% respectively to predict a hypotensive event at 5, 10, and 15 minutes before a hypotensive event. The HPI enable the treating anesthetist to proactive treat the predicted hypotension. Various studies have shown that HPI ability in reducing TWA-MAP < 65mmHg and significantly reduction in the incidence of IOH in major noncardiac surgery such as abdominal surgery, gastrointestinal surgery, spinal surgery, in elderly populations undergoing orthopedics surgery.

This study aim to implement intraoperative hemodynamic monitoring and management guided with HPI algorithm in frail patients undergoing elective abdominal surgery. Investigators hypothesize that the use of this algorithm will alter treatment of hypotension and reduces the amount of hypotension as measured by the time weighted average (TWA) during non-cardiac surgery and to anticipate a reduction of postoperative AKI incidents, to explore the clinical benefits of impact of Acumen guided algorithm hemodynamic management in postoperative intestinal function recovery, and postoperative cardiac complications.

Being tested
HPI guided hemodynamic management, standard arterial line
Keywords
intraoperative hypotension, hypotension prediction index, frail patient, acute kidney injury
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPI guided hemodynamic managementProcedure or surgery

    BP, ECG and SpO2 were monitored after entering the operating room, peripheral venous access was established, radial artery puncture catheterization under local anesthesia and connected to the HPI (Edwards Lifesciences).

    The treating anesthetist is trained to understand Acumen IQ parameters and the meaning of HPI, MAP, CI, SVI, SVR, SVV, Eadyn, dP/dtmax. The treating anesthetist is provided with guidance by means of a flowchart suggesting when to treat and how to treat hypotension. The hemodynamic management is performed according to the HPI guided algorithm.

  • standard arterial lineOther

    BP, ECG and SpO2 were monitored after entering the operating room, peripheral venous access was established, radial artery puncture catheterization under local anesthesia and connected to TruWave DPT and run data via HemoSphere machine (Edwards Lifesciences). The target of intraoperative blood pressure was to maintain MAP > 65mmHg. Timing of treatment and choice of treatment is then left to the discretion of the attending physician.

Study groups in NCT06909786
Study groupRoleWhat they receive
standard arterial line groupSham comparatorBP, ECG and SpO2 were monitored after entering the operating room, peripheral venous access was established, radial artery puncture catheterization under local anesthesia and connected to TruWave DPT and run data via HemoSphere machine (Edwards Lifesciences). The target of intraoperative blood pressure was to maintain MAP > 65mmHg. Timing of treatment and choice of treatment is then left to the discretion of the attending physician.
Receives: Other: standard arterial line
HPI guided hemodynamic management groupExperimentalBP, ECG and SpO2 were monitored after entering the operating room, peripheral venous access was established, radial artery puncture catheterization under local anesthesia and connected to the HPI (Edwards Lifesciences). The treating anesthetist is trained to understand Acumen IQ parameters and the meaning of HPI, MAP, CI, SVI, SVR, SVV, Eadyn, dP/dtmax. The treating anesthetist is provided with guidance by means of a flowchart suggesting when to treat and how to treat hypotension. The hemodynamic management is performed according to the HPI guided algorithm.
Receives: Procedure: HPI guided hemodynamic management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The occurrence of intraoperative hypotension

    Definition of intraoperative hypotension: MAP< 65mmHg lasting for> 1 minute. The occurrence of intraoperative hypotension: number of hypotension events, area under the hypotension curve, time-weighted average hypotension, total cumulative time of hypotension, ratio of cumulative total time of hypotension to length of operation

    Measured: From anesthesia to end of operation, assessed up to 8 hours.

Secondary outcomes (6)
  1. Incidents of AKI

    Definition of AKI according to KDIGO (Kidney Disease Improving Global Outcomes) criteria: elevated serum creatinine more than 0.3 mg/dl within 48 hours or more than 150% of basal value within 7 days, or urine output < 0.5 ml/kg/hour for more than 6 hours. The stages of AKI will not be divided.

    Measured: From end of operation to 48 hours after operation, up to 48 hours.

  2. Intestinal peristalsis recovery time

    Auscultation every 4 hours after surgery, and the appearance of ≥4 bowel sounds per minute is considered to be intestinal peristalsis recovery.

    Measured: From end of operation to first bowel movement, assessed up to 48 hours.

  3. Intestinal function recovery time

    Time from end of operation to first passage of flatus

    Measured: From end of operation to first passage of flatus, assessed up to 48 hours.

  4. Incidence of myocardiac injury

    Presence of ECG changes (bundle branch block, premature beats, or T-wave changes) or cardiographic enlargement or decreased cardiac function, elevated cTn/T >14 pg/ml and/or CK/MB elevated >8.8 ng/ml.

    Measured: From end of operation to 7 days after operation, up to 7 days.

  5. Incidence of congestive heart failure

    Pulmonary edema with clinical or radiographic evidence, requiring diuretic or vasodilator therapy, oxygen saturation less than 93% with or without mechanical ventilation.

    Measured: From end of operation to 7 days after operation, up to 7 days.

  6. Incidence of acute myocardial infarction

    Elevated troponin with at least one of the following: symptoms of myocardial ischemia, new-onset ECG changes (Q-wave formation, left bundle branch block), local ventricular wall motion abnormalities.

    Measured: From end of operation to 7 days after operation, up to 7 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06909786
Sponsor's protocol ID
XJTU1AF2024LSYY-152
Status last verified
Mar 2025
First submitted
23 Mar 2025
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing HPI guided hemodynamic management and standard arterial line in people with Intraoperative Hypotension, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 Zheng Guan (86-13572592715, guanzheng@xjtufh.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of intraoperative hypotension (time frame: From anesthesia to end of operation, assessed up to 8 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Apr 2025.

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