HypotensionNCT03938480
Duration Threstholds of Intraoperative Hypotension
An observational study of Hypotension, run by Peking University First Hospital at 1 site in China.
Trial summary
Intraoperative hypotension is common in non cardiac surgery. longer duration of intraoperative hypotension is related with postoperative morbidity and mortality. however, with the change of hypotension criteria, the duration threshold also change. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypotension
- How many people
- 37,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 22 May 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The analysis set of this study was adults (age ≥ 18 years old) who underwent elective non-cardiac surgery from January 1, 2012, to December 31, 2017.
Who may be able to join
- adults underwent elective non-cardiac surgery
Who cannot join
- cardiac surgeries; kidney surgeries; obstetric surgeries; local infiltration anesthesia; surgeries without arterial pressure monitoring; perioperative data missing; patients with more than one operation within a year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duration Threstholds of Intraoperative Hypotension for Postoperative Major Adverse Events
Intraoperative hypotension is common in non cardiac surgery. longer duration of intraoperative hypotension is related with postoperative morbidity and mortality. however, with the change of hypotension criteria, the duration threshold also change. the relationship of different hypotension criteria and its duration is unclear. This study is to explore the their relationship.
Read the detailed description
Intraoperative hypotension is common in non cardiac surgery. longer duration of intraoperative hypotension is related with postoperative morbidity and mortality. however, with the change of hypotension criteria, the duration threshold also change. the relationship of different hypotension criteria and its duration is unclear. This study is to explore the relationship between continous difference mean blood pressure criteria and its duration thresholds for postoperative major adverse events, which include acute cardiac infarction, heart failure, cardiac death, stroke and acute kidney injury.
- Conditions
- Hypotension
- Medical subject headings
- Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse events
including acute cardiac infarction, heart failure, cardiac death, stroke, kidney injury
Measured: 30 days postoperatively in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Jan 2019
- Primary completion20 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- 37,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Zhou, MD, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938480
- Sponsor's protocol ID
- DTIH
- Status last verified
- Jun 2019
- First submitted
- 2 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration Threstholds of Intraoperative Hypotension for Postoperative Major Adverse Events
- ClinicalTrials.gov ID
- NCT03938480
- Acronym / sponsor ID
- DTIH
- Conditions
- Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37,000 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 6 May 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.
Intraoperative hypotension is common in non cardiac surgery. longer duration of intraoperative hypotension is related with postoperative morbidity and mortality. however, with the change of hypotension criteria, the duration threshold also change. the relationship of different hypotension criteria and its duration is unclear. This study is to explore the their relationship.
Detailed description
Intraoperative hypotension is common in non cardiac surgery. longer duration of intraoperative hypotension is related with postoperative morbidity and mortality. however, with the change of hypotension criteria, the duration threshold also change. the relationship of different hypotension criteria and its duration is unclear. This study is to explore the relationship between continous difference mean blood pressure criteria and its duration thresholds for postoperative major adverse events, which include acute cardiac infarction, heart failure, cardiac death, stroke and acute kidney injury.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The analysis set of this study was adults (age ≥ 18 years old) who underwent elective non-cardiac surgery from January 1, 2012, to December 31, 2017.
Key inclusion criteria (1 listed)
- adults underwent elective non-cardiac surgery
Key exclusion criteria (1 listed)
- cardiac surgeries; kidney surgeries; obstetric surgeries; local infiltration anesthesia; surgeries without arterial pressure monitoring; perioperative data missing; patients with more than one operation within a year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
major adverse events
Time frame: 30 days postoperatively in hospital
including acute cardiac infarction, heart failure, cardiac death, stroke, kidney injury
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 4 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypotension, run by Peking University First 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 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: finished, as of the sponsor's last update on 4 Jun 2019. 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?
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?
major adverse events (time frame: 30 days postoperatively in hospital). 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 Jun 2019.