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Intraoperative Hypotension and Metabolomics in Major Upper Gastrointestinal Surgery

Primary Purpose

the Intraoperative Hypotension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hypotension prediction index guidance
no hypotension prediction index guidance
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for the Intraoperative Hypotension

Eligibility Criteria

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

Inclusion Criteria: elective upper gastrointestinal surgery Exclusion Criteria: no laparoscopic surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    hypotension prediction index guided

    no hypotension prediction index guided

    Arm Description

    patients with hypotension prediction index guidance

    patients without hypotension prediction index guidance

    Outcomes

    Primary Outcome Measures

    time weighted average mean arterial pressure less than 65 mmHg
    the severity and duration of hypotension during surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    April 13, 2023
    Last Updated
    April 24, 2023
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05828862
    Brief Title
    Intraoperative Hypotension and Metabolomics in Major Upper Gastrointestinal Surgery
    Official Title
    Investigating the Effect of Hypotension Prediction Index Guidance on Intraoperative Hypotension and the Relationships Between the Metabolomic Profile and Postoperative Ileus in Patients Undergoing Major Upper Abdominal Surgery: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 22, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2028 (Anticipated)
    Study Completion Date
    December 31, 2029 (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
    We will investigate the effect of hypotension prediction index guidance on intraoperative hypotension and metabolomics in patients undergoing major upper gastrointestinal surgery
    Detailed Description
    Intraoperative hypotension (IOH) has been shown to increase the risk of postoperative morbidity and mortality. The Hypotension prediction index (HPI) guidance is an algorithm that can predict impending hypotension, defined as mean arterial pressure below 65mmHg. Patients undergoing major upper abdominal surgery are at high risk of IOH occurrence, because the surgical procedures involve organ removal like intestinal resection and vessel or organ anastomoses or reconstruction, often associated with high blood loss. However, the effectivity of applying HPI for reducing the duration and severity of IOH and postoperative morbidity and mortality in short term within 30 days after surgery and long term within 1 year remains inconclusive. Postoperative ileus (POI) generally defines absence of flatus within 72 hours after surgery. POI is known as the most important factor to slow patient recovery, increase postoperative morbidity and prolong the hospital stay following major upper abdominal surgery. Metabolomics can investigate the small molecule changes in response to certain stimulus, such as different environments. Metabolomics involves the comprehensive analysis of metabolites. In recent years, metabolomics has several applications in the early diagnosis and prevention of health and disease. However, the association between the POI occurrence and the metabolites in the presence and absence HPI guidance have not yet been investigated. The proposed strategy and specific objectives of this 2 years project using a randomized controlled trial are as the follows: To clarify the effect of HPI application on intraoperative hypotension prevention and postoperative complications in patients undergoing major upper abdominal surgery To clarify the relationship of POI occurrence to presence and absence of HPI guidance To Explore differences in metabolites in presence or absence of HPI guidance. Explore the potential metabolites associated with POI in different intraoperative environment in using HPI and no HPI guidance.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    patients with/without hypotension prediction index guidance
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    98 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    hypotension prediction index guided
    Arm Type
    Experimental
    Arm Description
    patients with hypotension prediction index guidance
    Arm Title
    no hypotension prediction index guided
    Arm Type
    Active Comparator
    Arm Description
    patients without hypotension prediction index guidance
    Intervention Type
    Procedure
    Intervention Name(s)
    hypotension prediction index guidance
    Intervention Description
    using hypotension prediction index guidance to prevent intraoperative hypotension
    Intervention Type
    Procedure
    Intervention Name(s)
    no hypotension prediction index guidance
    Intervention Description
    silencing hypotension prediction index guidance during surgery
    Primary Outcome Measure Information:
    Title
    time weighted average mean arterial pressure less than 65 mmHg
    Description
    the severity and duration of hypotension during surgery
    Time Frame
    surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: elective upper gastrointestinal surgery Exclusion Criteria: no laparoscopic surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chih-Jun Lai, MD
    Phone
    0223123456
    Email
    littlecherrytw@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    due to ethical issue

    Learn more about this trial

    Intraoperative Hypotension and Metabolomics in Major Upper Gastrointestinal Surgery

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