Intraoperative Hypotension and Metabolomics in Major Upper Gastrointestinal Surgery

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05828862

Collaborator

(none)

Enrollment

Arms

80.3

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
the Intraoperative Hypotension	Procedure: hypotension prediction index guidance Procedure: no hypotension prediction index guidance	N/A

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:

To clarify the effect of HPI application on intraoperative hypotension prevention and postoperative complications in patients undergoing major upper abdominal surgery
To clarify the relationship of POI occurrence to presence and absence of HPI guidance
To Explore differences in metabolites in presence or absence of HPI guidance.
Explore the potential metabolites associated with POI in different intraoperative environment in using HPI and no HPI guidance.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

patients with/without hypotension prediction index guidancepatients with/without hypotension prediction index guidance

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Apr 22, 2023

Anticipated Primary Completion Date :

Dec 31, 2028

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

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
Active Comparator: no hypotension prediction index guided patients without hypotension prediction index guidance	Procedure: no hypotension prediction index guidance silencing hypotension prediction index guidance during surgery

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

Active Comparator: no hypotension prediction index guided

patients without hypotension prediction index guidance

Procedure: no hypotension prediction index guidance

silencing hypotension prediction index guidance during surgery

Outcome Measures

Primary Outcome Measures

time weighted average mean arterial pressure less than 65 mmHg [surgery]
the severity and duration of hypotension during surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

elective upper gastrointestinal surgery

Exclusion Criteria:

no laparoscopic surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT05828862

Other Study ID Numbers:

202301110DIND

First Posted:

Apr 25, 2023

Last Update Posted:

Apr 25, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypotension

Study Results

No Results Posted as of Apr 25, 2023