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HPI in Older Patients Undergoing Major Gastrointestinal Surgery

Primary Purpose

the Severity and Duration of Intraoperative Hypotension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hypotension prediction index guided
without hypotesion prediction index guided
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for the Severity and Duration of Intraoperative Hypotension

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • the age of patients>=65 years old
  • patients receivedd major gastrointestinal surgery

Exclusion Criteria:

  • patients with major organ dysfunction, such as severe arrythmia, heart failure, under hemodialysis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    hypotension prediction index guided

    without hypotesion prediction index guided

    Arm Description

    Patients receiving hypotension prediction index guided. In this group, they will be alerted when the index exceeded 85 (range 0 to 100) indicating the later occurrence of MAP< 65mmHg for at least minutes and a treatment protocol based on advanced hemodynamic parameters recommended vasopressor or inotrope, fluid administration, or observation.

    Patients will receive usual care during the operation without hypotension prediction index alerted.

    Outcomes

    Primary Outcome Measures

    Time-weighted average mean arterial pressure less than 65 mmHg
    A higher data of time-weighted average mean arterial pressure less than 65 mmHg indicates severe and longer intraoperative hypotension

    Secondary Outcome Measures

    Full Information

    First Posted
    March 17, 2022
    Last Updated
    March 25, 2022
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05297318
    Brief Title
    HPI in Older Patients Undergoing Major Gastrointestinal Surgery
    Official Title
    Applying Hypotension Prediction Index Guidance for Prevention of Intraoperative Hypotension in Older Patients Undergoing Major Gastrointestinal Surgery: A Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 28, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2026 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)<65mmHg). In this study, we aimed to investigate whether HPI could prevent the intraoperative hypotension happened in patients receive elective major gastrointestinal surgery with older than 65 years old.
    Detailed Description
    Background: the incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)<65mmHg). Objectives: to investigate whether HPI could prevent the intraoperative hypotension happened. Patients and methods: The patients receive elective major gastrointestinal surgery with older than 65 years old. These patients have divided into two groups, including with/without HPI guided. The intraoperative hypotension incidence has been measured. Expected result: The HPI would significantly decrease the intraoperative hypotension incidence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    the Severity and Duration of Intraoperative Hypotension

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The patients receive elective major gastrointestinal surgery with older than 65 years old. These patients have divided into two groups, including with/without HPI guided. The intraoperative hypotension incidence has been measured.
    Masking
    ParticipantCare Provider
    Masking Description
    patients and care providers did not know the whether the hypotension prediction index use during the operation.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    hypotension prediction index guided
    Arm Type
    Experimental
    Arm Description
    Patients receiving hypotension prediction index guided. In this group, they will be alerted when the index exceeded 85 (range 0 to 100) indicating the later occurrence of MAP< 65mmHg for at least minutes and a treatment protocol based on advanced hemodynamic parameters recommended vasopressor or inotrope, fluid administration, or observation.
    Arm Title
    without hypotesion prediction index guided
    Arm Type
    Sham Comparator
    Arm Description
    Patients will receive usual care during the operation without hypotension prediction index alerted.
    Intervention Type
    Device
    Intervention Name(s)
    hypotension prediction index guided
    Intervention Description
    patients receiving hypotension prediction index monitoring and let the anesthesiologist' alerted the coming intraoperatiobe hypotension
    Intervention Type
    Other
    Intervention Name(s)
    without hypotesion prediction index guided
    Intervention Description
    patients receiving usual care without hypotension prediction index monitoring but with usual arterial line care
    Primary Outcome Measure Information:
    Title
    Time-weighted average mean arterial pressure less than 65 mmHg
    Description
    A higher data of time-weighted average mean arterial pressure less than 65 mmHg indicates severe and longer intraoperative hypotension
    Time Frame
    preoperative and postoperative 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: the age of patients>=65 years old patients receivedd major gastrointestinal surgery Exclusion Criteria: patients with major organ dysfunction, such as severe arrythmia, heart failure, under hemodialysis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chih-Jun Lai, MD
    Phone
    0223123456
    Ext
    62158
    Email
    littlecherrytw@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    ‪Kuo-Liong Chien, PD
    Phone
    33668017
    Email
    klchien@ntu.edu.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    ethical issue: patients' privacy

    Learn more about this trial

    HPI in Older Patients Undergoing Major Gastrointestinal Surgery

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