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RecruitingNCT05828862Updated Sep 19, 2024

Intraoperative Hypotension and Metabolomics in Major Upper Gastrointestinal Surgery

An interventional study of hypotension prediction index guidance in the Intraoperative Hypotension, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • the Intraoperative Hypotension

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03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's planned enrollment of 85 is close to the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • elective upper gastrointestinal surgery

Exclusion criteria

Exclusion Criteria:

  • no laparoscopic surgery
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (estimated)

Study arms

  • Experimental
    hypotension prediction index guided

    patients with hypotension prediction index guidance

    Procedure: hypotension prediction index guidance

Interventions

  • Procedurehypotension prediction index guidance

    using hypotension prediction index guidance to prevent intraoperative hypotension

06

What researchers measure

Primary outcomes

  1. time weighted average mean arterial pressure less than 65 mmHg

    the severity and duration of hypotension during surgery

    Time frame: surgery

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    • Chih-Jun Lai, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — due to ethical issue

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05828862
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Apr 25, 2023
Start date
Apr 22, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 19, 2024

Study contacts

Chih-Jun Lai, MD
Contact
littlecherrytw@gmail.com
0223123456

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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