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Recruiting NCT05828862

Intraoperative Hypotension and Metabolomics in Major Upper Gastrointestinal Surgery

No phase Interventional the Intraoperative Hypotension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hypotension prediction index guidance.
Who it may be relevant to
Registry conditions: the Intraoperative Hypotension. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

  • Procedure hypotension prediction index guidance
    using hypotension prediction index guidance to prevent intraoperative hypotension

Primary outcome measures

  • time weighted average mean arterial pressure less than 65 mmHg [Time frame: surgery]

Eligibility criteria

Inclusion criteria

  • elective upper gastrointestinal surgery

Exclusion criteria

  • no laparoscopic surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT05828862 · 202301110DIND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗