Perioperative ComplicationNCT04117867
The Association Between Intraoperative Hypotension and Perioperative Stroke
An observational study of Perioperative Complication and Intraoperative Hypotension, run by Qianfoshan Hospital at 1 site in China.
Trial summary
The aim of this study is to investigate the association between the severity and duration of intraoperative hypotension and the incidence of perioperative stroke after non-cardiac and non-neurologic surgeries.The secondary aim of this study is to confirm the potential risk factors of the perioperative stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Complication, Intraoperative Hypotension
- What is being tested?
- Patiens with intraoperative hypotension
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2019to 1 Nov 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent surgical procedures under anesthesia at Qianfoshan Hospital, First Hospital affiliated to Shandong First Medical University during the period from January, 2013, to October, 2019, will be included.
Who may be able to join
- Patients underwent surgeries in First hospital affiliated to Shandong First Medical University from January 2013 to October 2019
- Age>18 or older
Who cannot join
- Patients received local infiltration anesthesia
- Patients underwent total intravenous anesthsia without tracheal intubation or Laryngeal Mask Airway insertion
- Major vascular operation
- Neurologic surgery
- Cariac surgery
- Intraoperative blood pressure measurements or postoperative neuroimagings measurements are not available
- History of severe neurological or psychiatric disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First affiliated hospital of Shandong First Medical University
Jinan, Shandong
Lili Cao, PH.D
Yuelan Wang, PH.D
About this study
Official title: The Association Between Intraoperative Hypotension and Perioperative Stroke in General Surgery Patients: a Retrospective, Hospital-based Study in China
The aim of this study is to investigate the association between the severity and duration of intraoperative hypotension and the incidence of perioperative stroke after non-cardiac and non-neurologic surgeries.The secondary aim of this study is to confirm the potential risk factors of the perioperative stroke.
Read the detailed description
Optimized intraoperative management may play an important role in perioperative stroke prevention. Maintaining blood pressure near preoperative baseline values may help decrease the incidence of stroke, however the related evidence is limited.Therefore, this study is to investigate the association between intraoperative hemodynamic variable and the risk of perioperative stroke after non-cardiac and non-neurologic surgeries. The secondary aim of this study is to establish the potential risk factors of the perioperative stroke.
- Being tested
- Patiens with intraoperative hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patiens with intraoperative hypotensionBehavioural
In this study, we will use four previously defined thresholds for intraoperative hypotension: two absolute thresholds (MAP less than 50 mmHg and MAP less than 60 mmHg) and two relative thresholds to the baseline MAP (a decrease of 30% or more and a decrease of 40% or more). A definition of baseline value most frequently reported was the arterial blood pressure before the induction of anesthesia. Therefore, the baseline MAP used in calculating the relative thresholds is defined as the mean MAP of all available blood pressure measurements before induction of anesthesia in the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative hypotension | Not described Receives: Behavioral: Patiens with intraoperative hypotension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perioperative stroke
Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs
Measured: Within 24 hours after surgery
Incidence of perioperative stroke
Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs
Measured: Within 3 days after surgery
Incidence of perioperative stroke
Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs
Measured: Within 7 days after surgery
Incidence of perioperative stroke
Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs
Measured: Within 30 days after surgery
Secondary outcomes (5)
Rate of death
Death from any cause
Measured: Within 24 hours after surgery
Rate of death
Death from any cause
Measured: Within 3 days after surgery
Rate of death
Death from any cause
Measured: Within 7 days after surgery
Rate of death
Death from any cause
Measured: Within 30 days after surgery
Expense of Healthe care and social service
The expense of Healthe care and social service that the patients spent in hospital
Measured: Through study completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start30 Dec 2019
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Yuelan Wang, Doctor, Principal investigator, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117867
- Sponsor's protocol ID
- IOHPS
- Status last verified
- Dec 2020
- First submitted
- 27 Sep 2019
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Intraoperative Hypotension and Perioperative Stroke in General Surgery Patients: a Retrospective, Hospital-based Study in China
- ClinicalTrials.gov ID
- NCT04117867
- Acronym / sponsor ID
- IOHPS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70,000 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 7 Oct 2019 (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 aim of this study is to investigate the association between the severity and duration of intraoperative hypotension and the incidence of perioperative stroke after non-cardiac and non-neurologic surgeries.The secondary aim of this study is to confirm the potential risk factors of the perioperative stroke.
Detailed description
Optimized intraoperative management may play an important role in perioperative stroke prevention. Maintaining blood pressure near preoperative baseline values may help decrease the incidence of stroke, however the related evidence is limited.Therefore, this study is to investigate the association between intraoperative hemodynamic variable and the risk of perioperative stroke after non-cardiac and non-neurologic surgeries. The secondary aim of this study is to establish the potential risk factors of the perioperative stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative hypotension | – | Behavioral: Patiens with intraoperative hypotension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent surgical procedures under anesthesia at Qianfoshan Hospital, First Hospital affiliated to Shandong First Medical University during the period from January, 2013, to October, 2019, will be included.
Key inclusion criteria (2 listed)
- Patients underwent surgeries in First hospital affiliated to Shandong First Medical University from January 2013 to October 2019
- Age>18 or older
Key exclusion criteria (7 listed)
- Patients received local infiltration anesthesia
- Patients underwent total intravenous anesthsia without tracheal intubation or Laryngeal Mask Airway insertion
- Major vascular operation
- Neurologic surgery
- Cariac 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 |
|---|---|---|
| Patiens with intraoperative hypotensionIn this study, we will use four previously defined thresholds for intraoperative hypotension: two absolute thresholds (MAP less than 50 mmHg and MAP less than 60 mmHg) and two relative thresholds to the baseline MAP (a decrease of 30% or more and a decrease of 40% or more). A definition of baseline value most frequently reported was the arterial blood pressure before the induction of anesthesia. Therefore, the baseline MAP used in calculating the relative thresholds is defined as the mean MAP of all available blood pressure measurements before induction of anesthesia in the operating room. | Behavioural | Intraoperative hypotension |
Primary outcome
Incidence of perioperative stroke
Time frame: Within 24 hours after surgery
Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs
Incidence of perioperative stroke
Time frame: Within 3 days after surgery
Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs
Incidence of perioperative stroke
Time frame: Within 7 days after surgery
Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs
Incidence of perioperative stroke
Time frame: Within 30 days after surgery
Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs
5 secondary outcomes
Rate of death
Time frame: Within 24 hours after surgery
Rate of death
Time frame: Within 3 days after surgery
Rate of death
Time frame: Within 7 days after surgery
Rate of death
Time frame: Within 30 days after surgery
Expense of Healthe care and social service
Time frame: Through study completion, an average of 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: Yes
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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.
Yuelan Wang, Doctor principal investigator
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Complication and Intraoperative Hypotension, run by Qianfoshan Hospital at 1 site in China.
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 7 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 4 Dec 2020. 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 China. 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 Yuelan Wang, Doctor (+86053189268535, qylvmeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of perioperative stroke (time frame: Within 24 hours after surgery). The study lists 4 primary outcomes in all. 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 4 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.