Intraoperative Hypotension and Metabolomics in Major Upper Gastrointestinal Surgery

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

We will investigate the effect of hypotension prediction index guidance on intraoperative hypotension and metabolomics in patients undergoing major upper gastrointestinal surgery

Study Overview

• Status: Recruiting
• Conditions: the Intraoperative Hypotension
• Intervention / Treatment: Procedure: hypotension prediction index guidance

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:

1. To clarify the relationship of POI occurrence to presence and absence of HPI guidance
2. To Explore differences in metabolites in presence or absence of HPI guidance.
3. Explore the potential metabolites associated with POI in different intraoperative environment in using HPI and no HPI guidance.

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chih-Jun Lai, MD; Phone Number: 0223123456; Email: littlecherrytw@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chih-Jun Lai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• elective upper gastrointestinal surgery

Exclusion Criteria:

• no laparoscopic surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hypotension prediction index guided; patients with hypotension prediction index guidance	Procedure: hypotension prediction index guidance; using hypotension prediction index guidance to prevent intraoperative hypotension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time weighted average mean arterial pressure less than 65 mmHg	the severity and duration of hypotension during surgery	surgery

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 202301110DIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: due to ethical issue

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No