Intraoperative Hypotension and Metabolomics in Major Upper Gastrointestinal Surgery

NCT ID: NCT05828862

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-22
• Study Completion Date: 2029-12-31

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:

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.

Conditions

the Intraoperative Hypotension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

hypotension prediction index guided

patients with hypotension prediction index guidance

Group Type: EXPERIMENTAL

hypotension prediction index guidance

Intervention Type: PROCEDURE

using hypotension prediction index guidance to prevent intraoperative hypotension

Interventions

hypotension prediction index guidance

using hypotension prediction index guidance to prevent intraoperative hypotension

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• elective upper gastrointestinal surgery

Exclusion Criteria

• no laparoscopic surgery

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chih-Jun Lai, MD

Role: CONTACT

littlecherrytw@gmail.com

0223123456

Facility Contacts

Chih-Jun Lai, MD

Role: primary

Other Identifiers

202301110DIND

Identifier Type: -

Identifier Source: org_study_id