Valvular SurgeryNCT05211934
Relationship Between Postoperative Delirium and Heart Function in Valvular Surgery
An observational study of Valvular Surgery, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Delirium is an acute brain lesion characterized by abnormalities of consciousness, attention, cognition and sensation. Many brain diseases such as stroke, traumatic brain injury and intracranial hypertension can lead to cardiac insufficiency, arrhythmia and heart failure. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Valvular Surgery
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jul 2024
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing valvular surgery in our hospital were selected. The age was 60 years ≤ age ≤75 years, and gender was not limited. According to the occurrence of postoperative delirium, the patients were divided into postoperative delirium group and Non-postoperative delirium group.
Who may be able to join
- Patients undergoing valvular surgery
- Age between 60 to 75
Who cannot join
- Have a history of cerebral infarction before operation
- Cardiac function was seriously impaired before surgery
- Neuropsychiatric disorders were present before surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anzhen hospital, Beijing
Beijing, Beijing Municipality, 100029
Jun Ma, PhD, 13370103571, majun7689@163.com
About this study
Official title: Relationship Between Postoperative Delirium and Heart Function in Valvular Surgery：A Prospective Observational Cohort Study
Delirium is an acute brain lesion characterized by abnormalities of consciousness, attention, cognition and sensation. Many brain diseases such as stroke, traumatic brain injury and intracranial hypertension can lead to cardiac insufficiency, arrhythmia and heart failure. The incidence of postoperative delirium in patients undergoing cardiac surgery is high. Postoperative delirium is a manifestation of brain function injury. The effect of postoperative delirium on postoperative cardiac function in patients undergoing cardiac surgery is worthy of further discussion.
- Conditions
- Valvular Surgery
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| The group with delirium | Not described Receives: Other: No intervention | |
| The group without delirium | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart function
Doses of norepinephrine, epinephrine, dopamine, dobutamine and vasopressin
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular SurgeryStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ma, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211934
- Sponsor's protocol ID
- 20220101
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Postoperative Delirium and Heart Function in Valvular Surgery：A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05211934
- Acronym / sponsor ID
- 20220101
- Conditions
- Valvular Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 27 Jan 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.
Delirium is an acute brain lesion characterized by abnormalities of consciousness, attention, cognition and sensation. Many brain diseases such as stroke, traumatic brain injury and intracranial hypertension can lead to cardiac insufficiency, arrhythmia and heart failure. The incidence of postoperative delirium in patients undergoing cardiac surgery is high. Postoperative delirium is a manifestation of brain function injury. The effect of postoperative delirium on postoperative cardiac function in patients undergoing cardiac surgery is worthy of further discussion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group with delirium | – | Other: No intervention |
| The group without delirium | – | Other: No intervention |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing valvular surgery in our hospital were selected. The age was 60 years ≤ age ≤75 years, and gender was not limited. According to the occurrence of postoperative delirium, the patients were divided into postoperative delirium group and Non-postoperative delirium group.
Key inclusion criteria (2 listed)
- Patients undergoing valvular surgery
- Age between 60 to 75
Key exclusion criteria (3 listed)
- Have a history of cerebral infarction before operation
- Cardiac function was seriously impaired before surgery
- Neuropsychiatric disorders were present before 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 |
|---|---|---|
| No interventionNo intervention | Other | The group with delirium, The group without delirium |
Primary outcome
heart function
Time frame: up to 60 days
Doses of norepinephrine, epinephrine, dopamine, dobutamine and vasopressin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
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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.
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 Valvular Surgery, run by Beijing Anzhen 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 3 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 27 Jan 2022. 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 Jun Ma (13370103571, majun7689@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart function (time frame: up to 60 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 27 Jan 2022.