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

Primary Purpose

Orthopedic Disorder, Hemodynamic Instability

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
hypotension prediction index(HPI)
ordinary goal-directed hemodynamic therapy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Orthopedic Disorder

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

HPI group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Perioperative acute kidney injury
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.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2022
Last Updated
March 27, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05274412
Brief Title
Hypotension Prediction Index Based Perioperative Protocolized Hemodynamic Management in Geriatric Orthopedic Surgery
Official Title
Clinical Efficacy of Hypotension Prediction Index Based Perioperative Protocolized Hemodynamic Management in Geriatric Orthopedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder, Hemodynamic Instability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HPI group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
hypotension prediction index(HPI)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ordinary goal-directed hemodynamic therapy
Intervention Description
Keep pulse pressure variation >12%; keep cardiac index >2L/min/cm^2; keep mean arterial pressure > 65mmHg.
Primary Outcome Measure Information:
Title
Perioperative acute kidney injury
Description
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.
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
perioperative neurocognitive disorder
Description
Taiwan version of quick mild cognitive impairment(Qmci) test will be used to identify perioperative neurocognitive disorder
Time Frame
30 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen-Tse Lee, MD
Phone
0972653169
Email
lctbrian314@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen-Tse Lee, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen-Tse Lee, M.D.
Phone
0972653169
Email
lctbrian314@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26083768
Citation
Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756. Erratum In: Anesthesiology. 2016 Mar;124(3):741-2.
Results Reference
background
PubMed Identifier
30236233
Citation
Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
Results Reference
background
PubMed Identifier
29894315
Citation
Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.
Results Reference
result
PubMed Identifier
32065827
Citation
Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
Results Reference
result

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

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