Orthopedic DisorderNCT05274412
Hypotension Prediction Index Based Perioperative Protocolized Hemodynamic Management in Geriatric Orthopedic Surgery
A study testing hypotension prediction index(HPI) and ordinary goal-directed hemodynamic therapy in people with Orthopedic Disorder and Hemodynamic Instability, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Blood pressure optimization has been considered as a crucial factor to avoid perioperative vital organ hypoperfusion, and perioperative hypotension has been addressed as a risk factor for complications and adverse clinical outcomes. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Orthopedic Disorder, Hemodynamic Instability
- What is being tested?
- hypotension prediction index(HPI) and ordinary goal-directed hemodynamic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Mar 2022to Apr 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults elder or equal to 60 years old receiving scheduled orthopedic surgery
Who cannot join
- Patients with a history of arrhythmia, congestive heart failure, preoperative neurocognitive disorder, cerebrovascular event, chronic obstructive pulmonary disease, chronic kidney disease, ongoing infectious disease, will be excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chen-Tse Lee, M.D., 0972653169, lctbrian314@gmail.com
About this study
Official title: Clinical Efficacy of Hypotension Prediction Index Based Perioperative Protocolized Hemodynamic Management in Geriatric Orthopedic Surgery
Blood pressure optimization has been considered as a crucial factor to avoid perioperative vital organ hypoperfusion, and perioperative hypotension has been addressed as a risk factor for complications and adverse clinical outcomes.
Hypotension prediction index (HPI) is an novel machine-learning derived parameters, and was developed to predict the risk of future hypotension.Series of clinical studies have verified its clinical efficacy in avoiding perioperative hypotension.
Major orthopedic surgeries, such as spine surgery, joint surgery, long bone fracture surgery, are quite common in elder people, who are vulnerable to perioperative adverse outcomes.Thus the investigator design this study to testify the clinical efficacy of implementing HPI in perioperative goal-directed hemodynamic therapy in elder patients receiving major orthopedic surgery.
- Conditions
- Orthopedic Disorder, Hemodynamic Instability
- Being tested
- hypotension prediction index(HPI), ordinary goal-directed hemodynamic therapy
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypotension prediction index(HPI)Other
Implementing hypotension prediction index (HPI) in perioperative goal-directed hemodynamic therapy. Keep HPI < 85; pulse pressure variation >12%; keep cardiac index >2L/min/cm^2; keep mean arterial pressure > 65mmHg.
ordinary goal-directed hemodynamic therapyOther
Keep pulse pressure variation >12%; keep cardiac index >2L/min/cm^2; keep mean arterial pressure > 65mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participants in this group will receive protocolized hemodynamic management based on advanced hemodynamic monitoring and dynamic parameters.Keep pulse pressure variation >12%; keep cardiac index >2L/min/cm^2; keep mean arterial pressure > 65mmHg. Receives: Other: ordinary goal-directed hemodynamic therapy |
| HPI group | Experimental | Participants in this group will receive protocolized hemodynamic management based on advanced hemodynamic monitoring, hypotension prediction index (HPI), and dynamic parameters.Keep HPI <85; pulse pressure variation >12%; keep cardiac index >2L/min/cm^2; keep mean arterial pressure > 65mmHg. Receives: Other: hypotension prediction index(HPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative acute kidney injury
Acute kidney injury will be assessed according to the KDIGO guideline. Serum creatinine will be examined on the day before surgery and postoperative day 1.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start23 Mar 2022
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen-Tse Lee, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274412
- Sponsor's protocol ID
- 202112163RIND
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.
PubMed 26083768Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
PubMed 30236233Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.
PubMed 29894315Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
PubMed 32065827
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Hypotension Prediction Index Based Perioperative Protocolized Hemodynamic Management in Geriatric Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT05274412
- Acronym / sponsor ID
- 202112163RIND
- Conditions
- Orthopedic Disorder, Hemodynamic Instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 10 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.
Blood pressure optimization has been considered as a crucial factor to avoid perioperative vital organ hypoperfusion, and perioperative hypotension has been addressed as a risk factor for complications and adverse clinical outcomes.
Hypotension prediction index (HPI) is an novel machine-learning derived parameters, and was developed to predict the risk of future hypotension.Series of clinical studies have verified its clinical efficacy in avoiding perioperative hypotension.
Major orthopedic surgeries, such as spine surgery, joint surgery, long bone fracture surgery, are quite common in elder people, who are vulnerable to perioperative adverse outcomes.Thus the investigator design this study to testify the clinical efficacy of implementing HPI in perioperative goal-directed hemodynamic therapy in elder patients receiving major orthopedic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: ordinary goal-directed hemodynamic therapyParticipants in this group will receive protocolized hemodynamic management based on advanced hemodynamic monitoring and dynamic parameters.Keep pulse pressure variation >12%; keep cardiac index >2L/min/cm^2; keep mean arterial pressure > 65mmHg. |
| HPI group | Experimental | Other: hypotension prediction index(HPI)Participants in this group will receive protocolized hemodynamic management based on advanced hemodynamic monitoring, hypotension prediction index (HPI), and dynamic parameters.Keep HPI <85; pulse pressure variation >12%; keep cardiac index >2L/min/cm^2; keep mean arterial pressure > 65mmHg. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults elder or equal to 60 years old receiving scheduled orthopedic surgery
Key exclusion criteria (1 listed)
- Patients with a history of arrhythmia, congestive heart failure, preoperative neurocognitive disorder, cerebrovascular event, chronic obstructive pulmonary disease, chronic kidney disease, ongoing infectious disease, will be excluded.
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(HPI)Implementing hypotension prediction index (HPI) in perioperative goal-directed hemodynamic therapy. Keep HPI < 85; pulse pressure variation >12%; keep cardiac index >2L/min/cm^2; keep mean arterial pressure > 65mmHg. | Other | HPI group |
| ordinary goal-directed hemodynamic therapyKeep pulse pressure variation >12%; keep cardiac index >2L/min/cm^2; keep mean arterial pressure > 65mmHg. | Other | Control group |
Primary outcome
Perioperative acute kidney injury
Time frame: 24 hours
Acute kidney injury will be assessed according to the KDIGO guideline. Serum creatinine will be examined on the day before surgery and postoperative day 1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Background: PubMed 26083768Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.
- Background: PubMed 30236233Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
- Results publication: PubMed 29894315Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.
- Results publication: PubMed 32065827Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
- Individual participant dataSharing planned: No
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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.
Chen-Tse Lee, 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(HPI) and ordinary goal-directed hemodynamic therapy in people with Orthopedic Disorder and Hemodynamic Instability, 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: status not confirmed, as of the sponsor's last update on 29 Mar 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen-Tse Lee, MD (0972653169, lctbrian314@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative acute kidney injury (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274412, which also lists 4 linked publications.
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 29 Mar 2023.