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
About this trial
This is an interventional prevention trial for the Intraoperative Hypotension
Eligibility Criteria
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
NCT ID
NCT05828862
First Posted
April 13, 2023
Last Updated
April 24, 2023
Sponsor
National Taiwan University Hospital
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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