Hypotension Prediction Index and Intraoperative Hypotension Incidence

NCT06909786 | Not Yet Recruiting DMC

• 1 other identifier: XJTU1AF2024LSYY-152
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Intraoperative Hypotension

Keywords

intraoperative hypotension; hypotension prediction index; frail patient; acute kidney injury

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (6)

• Incidents of AKI

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

• Intestinal peristalsis recovery time

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

• Intestinal function recovery time

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

• Incidence of myocardiac injury

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

• Incidence of congestive heart failure

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

Other Outcomes (5)

• Mechanical ventilation support time

  From anesthesia induction to anesthesia recovery, assessed up to 24 hours.

• PACU time

  From admitted in PACU to discharged from PACU, assessed up to 24 hours.

• ICU time

  From admitted in ICU to discharged from ICU, assessed up to 3 days.

Study Arms (2)

standard arterial line group

SHAM COMPARATOR

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.

Other: standard arterial line

HPI guided hemodynamic management group

EXPERIMENTAL

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.

Procedure: HPI guided hemodynamic management

Interventions

HPI guided hemodynamic management PROCEDURE

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.

HPI guided hemodynamic management group

standard arterial line OTHER

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.

standard arterial line group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zheng Guan

CONTACT

86-13572592715; guanzheng@xjtufh.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)