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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05274412
Enrollment
280
Registered
2022-03-10
Start date
2022-03-23
Completion date
2024-04-30
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability, Orthopedic Disorder

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.

Interventions

OTHERhypotension prediction index(HPI)

Implementing hypotension prediction index (HPI) in perioperative goal-directed hemodynamic therapy. Keep HPI \< 85; pulse pressure variation \>12%; keep cardiac index \>2L/min/cm\^2; keep mean arterial pressure \> 65mmHg.

OTHERordinary goal-directed hemodynamic therapy

Keep pulse pressure variation \>12%; keep cardiac index \>2L/min/cm\^2; keep mean arterial pressure \> 65mmHg.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Perioperative acute kidney injury24 hoursAcute kidney injury will be assessed according to the KDIGO guideline. Serum creatinine will be examined on the day before surgery and postoperative day 1.

Other

MeasureTime frameDescription
perioperative neurocognitive disorder30 dayTaiwan version of quick mild cognitive impairment(Qmci) test will be used to identify perioperative neurocognitive disorder

Countries

Taiwan

Contacts

Primary ContactChen-Tse Lee, MD
lctbrian314@gmail.com0972653169

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026