the Intraoperative HypotensionNCT05828862
Intraoperative Hypotension and Metabolomics in Major Upper Gastrointestinal Surgery
A study testing hypotension prediction index guidance in people with the Intraoperative Hypotension, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
We will investigate the effect of hypotension prediction index guidance on intraoperative hypotension and metabolomics in patients undergoing major upper gastrointestinal surgery Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- the Intraoperative Hypotension
- What is being tested?
- hypotension prediction index guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Apr 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective upper gastrointestinal surgery
Who cannot join
- no laparoscopic surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chih-Jun Lai, MD
About this study
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
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:
- 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.
- Conditions
- the Intraoperative Hypotension
- Being tested
- hypotension prediction index guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypotension prediction index guidanceProcedure or surgery
using hypotension prediction index guidance to prevent intraoperative hypotension
| Study group | Role | What they receive |
|---|---|---|
| hypotension prediction index guided | Experimental | patients with hypotension prediction index guidance Receives: Procedure: hypotension prediction index guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
time weighted average mean arterial pressure less than 65 mmHg
the severity and duration of hypotension during surgery
Measured: surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start22 Apr 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients undergoing Hypotension Prediction Index
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828862
- Sponsor's protocol ID
- 202301110DIND
- Status last verified
- Sep 2024
- First submitted
- 13 Apr 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to ethical issue
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05828862
- Acronym / sponsor ID
- 202301110DIND
- Conditions
- the Intraoperative Hypotension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 22 Apr 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients undergoing Hypotension Prediction Index
| Arm | Type | Receives |
|---|---|---|
| hypotension prediction index guided | Experimental | Procedure: hypotension prediction index guidancepatients with hypotension prediction index guidance |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective upper gastrointestinal surgery
Key exclusion criteria (1 listed)
- no laparoscopic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypotension prediction index guidanceusing hypotension prediction index guidance to prevent intraoperative hypotension | Procedure or surgery | hypotension prediction index guided |
Primary outcome
time weighted average mean arterial pressure less than 65 mmHg
Time frame: surgery
the severity and duration of hypotension during surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. due to ethical issue
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Noradrenaline Versus Standard Blood Pressure Management for Perioperative Hypotension in Non-cardiac Surgery
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Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypotension prediction index guidance in people with the Intraoperative Hypotension, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Jun Lai, MD (0223123456, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time weighted average mean arterial pressure less than 65 mmHg (time frame: surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.