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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05274412
Collaborator
(none)
280
2
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: hypotension prediction index(HPI)
  • Other: ordinary goal-directed hemodynamic therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Clinical Efficacy of Hypotension Prediction Index Based Perioperative Protocolized Hemodynamic Management in Geriatric Orthopedic Surgery
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control group

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.

Other: ordinary goal-directed hemodynamic therapy
Keep pulse pressure variation >12%; keep cardiac index >2L/min/cm^2; keep mean arterial pressure > 65mmHg.

Experimental: HPI group

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.

Other: hypotension 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.

Outcome Measures

Primary Outcome Measures

  1. Perioperative acute kidney injury [24 hr]

    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.

Other Outcome Measures

  1. perioperative neurocognitive disorder [30 day]

    Taiwan version of quick mild cognitive impairment(Qmci) test will be used to identify perioperative neurocognitive disorder

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: Chen-Tse Lee, MD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05274412
Other Study ID Numbers:
  • 202112163RIND
First Posted:
Mar 10, 2022
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2022