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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05828862
Enrollment
85
Registered
2023-04-25
Start date
2023-04-22
Completion date
2029-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the Intraoperative Hypotension

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.

Interventions

PROCEDUREhypotension prediction index guidance

using hypotension prediction index guidance to prevent intraoperative hypotension

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

patients undergoing Hypotension Prediction Index

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* elective upper gastrointestinal surgery

Exclusion criteria

* no laparoscopic surgery

Design outcomes

Primary

MeasureTime frameDescription
time weighted average mean arterial pressure less than 65 mmHgsurgerythe severity and duration of hypotension during surgery

Countries

Taiwan

Contacts

Primary ContactChih-Jun Lai, MD
littlecherrytw@gmail.com0223123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026