the Severity and Duration of Intraoperative HypotensionNCT05297318
HPI in Older Patients Undergoing Major Gastrointestinal Surgery
A study testing hypotension prediction index guided and without hypotesion prediction index guided in people with the Severity and Duration of Intraoperative Hypotension, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- the Severity and Duration of Intraoperative Hypotension
- What is being tested?
- hypotension prediction index guided and without hypotesion prediction index guided
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Mar 2022to 5 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- the age of patients>=65 years old
- patients receivedd major gastrointestinal surgery
Who cannot join
- patients with major organ dysfunction, such as severe arrythmia, heart failure, under hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applying Hypotension Prediction Index Guidance for Prevention of Intraoperative Hypotension in Older Patients Undergoing Major Gastrointestinal Surgery: A Randomized Trial
The incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)<65mmHg). In this study, we aimed to investigate whether HPI could prevent the intraoperative hypotension happened in patients receive elective major gastrointestinal surgery with older than 65 years old.
Read the detailed description
Background: the incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)<65mmHg).
Objectives: to investigate whether HPI could prevent the intraoperative hypotension happened.
Patients and methods: The patients receive elective major gastrointestinal surgery with older than 65 years old. These patients have divided into two groups, including with/without HPI guided. The intraoperative hypotension incidence has been measured.
Expected result: The HPI would significantly decrease the intraoperative hypotension incidence.
- Being tested
- hypotension prediction index guided, without hypotesion prediction index guided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypotension prediction index guidedDevice
patients receiving hypotension prediction index monitoring and let the anesthesiologist' alerted the coming intraoperatiobe hypotension
without hypotesion prediction index guidedOther
patients receiving usual care without hypotension prediction index monitoring but with usual arterial line care
| Study group | Role | What they receive |
|---|---|---|
| hypotension prediction index guided | Experimental | Patients receiving hypotension prediction index guided. In this group, they will be alerted when the index exceeded 85 (range 0 to 100) indicating the later occurrence of MAP< 65mmHg for at least minutes and a treatment protocol based on advanced hemodynamic parameters recommended vasopressor or inotrope, fluid administration, or observation. Receives: Device: hypotension prediction index guided |
| without hypotesion prediction index guided | Sham comparator | Patients will receive usual care during the operation without hypotension prediction index alerted. Receives: Other: without hypotesion prediction index guided |
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
A higher data of time-weighted average mean arterial pressure less than 65 mmHg indicates severe and longer intraoperative hypotension
Measured: preoperative and postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start28 Mar 2022
- Primary completion2 Oct 2023
- Study completion5 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Severity and Duration of 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients receive elective major gastrointestinal surgery with older than 65 years old. These patients have divided into two groups, including with/without HPI guided. The intraoperative hypotension incidence has been measured.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Jun Lai, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297318
- Sponsor's protocol ID
- 202112225DIND
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ethical issue: patients' privacy
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Hypotension Prediction Index Guidance for Prevention of Intraoperative Hypotension in Older Patients Undergoing Major Gastrointestinal Surgery: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05297318
- Acronym / sponsor ID
- 202112225DIND
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 28 Mar 2022 (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.
The incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)<65mmHg). In this study, we aimed to investigate whether HPI could prevent the intraoperative hypotension happened in patients receive elective major gastrointestinal surgery with older than 65 years old.
Detailed description
Background: the incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)<65mmHg).
Objectives: to investigate whether HPI could prevent the intraoperative hypotension happened.
Patients and methods: The patients receive elective major gastrointestinal surgery with older than 65 years old. These patients have divided into two groups, including with/without HPI guided. The intraoperative hypotension incidence has been measured.
Expected result: The HPI would significantly decrease the intraoperative hypotension incidence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The patients receive elective major gastrointestinal surgery with older than 65 years old. These patients have divided into two groups, including with/without HPI guided. The intraoperative hypotension incidence has been measured.
| Arm | Type | Receives |
|---|---|---|
| hypotension prediction index guided | Experimental | Device: hypotension prediction index guidedPatients receiving hypotension prediction index guided. In this group, they will be alerted when the index exceeded 85 (range 0 to 100) indicating the later occurrence of MAP< 65mmHg for at least minutes and a treatment protocol based on advanced hemodynamic parameters recommended vasopressor or inotrope, fluid administration, or observation. |
| without hypotesion prediction index guided | Sham comparator | Other: without hypotesion prediction index guidedPatients will receive usual care during the operation without hypotension prediction index alerted. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- the age of patients>=65 years old
- patients receivedd major gastrointestinal surgery
Key exclusion criteria (1 listed)
- patients with major organ dysfunction, such as severe arrythmia, heart failure, under hemodialysis
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 guidedpatients receiving hypotension prediction index monitoring and let the anesthesiologist' alerted the coming intraoperatiobe hypotension | Device | hypotension prediction index guided |
| without hypotesion prediction index guidedpatients receiving usual care without hypotension prediction index monitoring but with usual arterial line care | Other | without hypotesion prediction index guided |
Primary outcome
Time-weighted average mean arterial pressure less than 65 mmHg
Time frame: preoperative and postoperative 30 days
A higher data of time-weighted average mean arterial pressure less than 65 mmHg indicates severe and longer intraoperative hypotension
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No. ethical issue: patients' privacy
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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. This study is not recruiting at the moment.
Chih-Jun Lai, MD principal investigator
National Taiwan University Hospital
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 guided and without hypotesion prediction index guided in people with the Severity and Duration of 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 2 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: finished, as of the sponsor's last update on 21 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: preoperative and postoperative 30 days). 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 21 Nov 2023.