Hypotension Prediction Index Based Perioperative Protocolized Hemodynamic Management in Geriatric Orthopedic Surgery

Not Applicable

• Conditions: Orthopedic Disorder; Hemodynamic Instability
• Interventions: Other: hypotension prediction index(HPI); Other: ordinary goal-directed hemodynamic therapy

• Registration Number: NCT05274412
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Blood pressure optimization has been considered as a crucial factor to avoid perioperative vital organ hypoperfusion, and perioperative hypotension has been addressed as a risk factor for complications and adverse clinical outcomes.

Hypotension prediction index (HPI) is an novel machine-learning derived parameters, and was developed to predict the risk of future hypotension.Series of clinical studies have verified its clinical efficacy in avoiding perioperative hypotension.

Major orthopedic surgeries, such as spine surgery, joint surgery, long bone fracture surgery, are quite common in elder people, who are vulnerable to perioperative adverse outcomes.Thus the investigator design this study to testify the clinical efficacy of implementing HPI in perioperative goal-directed hemodynamic therapy in elder patients receiving major orthopedic surgery.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-10
• Study Start: 2022-03-23
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• adults elder or equal to 60 years old receiving scheduled orthopedic surgery

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Exclusion Criteria

• Patients with a history of arrhythmia, congestive heart failure, preoperative neurocognitive disorder, cerebrovascular event, chronic obstructive pulmonary disease, chronic kidney disease, ongoing infectious disease, will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPI group	hypotension prediction index(HPI)	Participants in this group will receive protocolized hemodynamic management based on advanced hemodynamic monitoring, hypotension prediction index (HPI), and dynamic parameters.Keep HPI \<85; pulse pressure variation \>12%; keep cardiac index \>2L/min/cm\^2; keep mean arterial pressure \> 65mmHg.
Control group	ordinary goal-directed hemodynamic therapy	Participants in this group will receive protocolized hemodynamic management based on advanced hemodynamic monitoring and dynamic parameters.Keep pulse pressure variation \>12%; keep cardiac index \>2L/min/cm\^2; keep mean arterial pressure \> 65mmHg.

Primary Outcome Measures

Name	Time	Method
Perioperative acute kidney injury	24 hours	Acute kidney injury will be assessed according to the KDIGO guideline. Serum creatinine will be examined on the day before surgery and postoperative day 1.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan