DeliriumNCT03351985
The Study of Post-operation Delirium and Prognosis of Cardiac Surgery Patients
An observational study of Delirium, run by Southeast University, China.
Trial summary
Delirium is the most common neurological complication of cardiac surgery patients and associated with poor prognosis. In recent years, the important role of quantitative electroencephalogram (qEEG) in brain function monitoring is becoming increasingly prominent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- quantitative electroencephalogram (qEEG)
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 31 Aug 2018
- 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
- Adult, Older adult
Study population: Adult patients receiving cardiac surgery
Who may be able to join
- The patients of cardiac surgery aged ≥18 years
- Signed informed consent
Who cannot join
- Patients with a history of any neurologic and psychiatric disease
- Cognitive disorder
- Stroke history in three years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: the Effect of Quantitative Electroencephalogram (qEEG) in Predictive of Post-operation Delirium and Prognosis of Cardiac Surgery Patients
Delirium is the most common neurological complication of cardiac surgery patients and associated with poor prognosis. In recent years, the important role of quantitative electroencephalogram (qEEG) in brain function monitoring is becoming increasingly prominent. The purpose of this study is to evaluate the effect of qEEG in predictive of post-operation delirium and prognosis of cardiac surgery patients.
- Conditions
- Delirium
- Being tested
- quantitative electroencephalogram (qEEG)
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quantitative electroencephalogram (qEEG)Device
the patients receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU
| Study group | Role | What they receive |
|---|---|---|
| Delirium Group | The cardiac surgery patients with delirium receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU Receives: Device: quantitative electroencephalogram (qEEG) | |
| Non-delirium Group | The cardiac surgery patients without delirium receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU Receives: Device: quantitative electroencephalogram (qEEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
amplitude integrated electroencephalogram (aEEG)
the electroencephalogram amplitude of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
Measured: 24 hours
Secondary outcomes (12)
alpha frequency band energy
the percentage of alpha frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
Measured: 24 hours
beta frequency band energy
the percentage of beta frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
Measured: 24 hours
theta frequency band energy
the percentage of theta frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
Measured: 24 hours
delta frequency band energy
the percentage of delta frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
Measured: 24 hours
alpha variability
the variability of alpha frequency band of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
Measured: 24 hours
arterial oxygen saturation (SaO2)
the level of arterial oxygen saturation (SaO2) of cardiac surgery patients when admitted to intensive care unit
Measured: 24 hours
central venous oxygen saturation (ScvO2)
the level of central venous oxygen saturation(ScvO2) of cardiac surgery patients when admitted to intensive care unit
Measured: 24 hours
neuron specific enolase (NSE)
the level of neuron specific enolase (NSE) of cardiac surgery patients when admitted to intensive care unit
Measured: 24 hours
interleukin-6 (IL-6)
the level of interleukin-6 (IL-6) of cardiac surgery patients when admitted to intensive care unit
Measured: 24 hours
troponin i (TNI)
the level of troponin i (TNI) of cardiac surgery patients when admitted to intensive care unit
Measured: 24 hours
high-sensitivity C-reactive protein (hs-CRP)
the level of high-sensitivity C-reactive protein (hs-CRP) of cardiac surgery patients when admitted to intensive care unit
Measured: 24 hours
N-terminal pro brain natriuretic peptide (NT-pro-BNP)
the level of N-terminal pro brain natriuretic peptide (NT-pro-BNP) of cardiac surgery patients when admitted to intensive care unit
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 posted24 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Liu Wenxue, master, Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351985
- Sponsor's protocol ID
- 2017ZDSYLL054-P01
- Status last verified
- Nov 2017
- First submitted
- 14 Nov 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo Z, Wan W, Liu W, Liu L, Yang Y, Yang C, Cui X. Quantitative electroencephalography predicts postoperative delirium in adult cardiac surgical patients from a prospective observational study. Sci Rep. 2024 Dec 28;14(1):31101. doi: 10.1038/s41598-024-82422-7.
PubMed 39730694
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Quantitative Electroencephalogram (qEEG) in Predictive of Post-operation Delirium and Prognosis of Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT03351985
- Acronym / sponsor ID
- 2017ZDSYLL054-P01
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 24 Nov 2017 (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 the most common neurological complication of cardiac surgery patients and associated with poor prognosis. In recent years, the important role of quantitative electroencephalogram (qEEG) in brain function monitoring is becoming increasingly prominent. The purpose of this study is to evaluate the effect of qEEG in predictive of post-operation delirium and prognosis of cardiac surgery patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium Group | – | Device: quantitative electroencephalogram (qEEG)The cardiac surgery patients with delirium receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU |
| Non-delirium Group | – | Device: quantitative electroencephalogram (qEEG)The cardiac surgery patients without delirium receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients receiving cardiac surgery
Key inclusion criteria (2 listed)
- The patients of cardiac surgery aged ≥18 years
- Signed informed consent
Key exclusion criteria (3 listed)
- Patients with a history of any neurologic and psychiatric disease
- Cognitive disorder
- Stroke history in three years
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 |
|---|---|---|
| quantitative electroencephalogram (qEEG)the patients receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU | Device | Delirium Group, Non-delirium Group |
Primary outcome
amplitude integrated electroencephalogram (aEEG)
Time frame: 24 hours
the electroencephalogram amplitude of cardiac surgery patients assessed by quantitative electroencephalogram when admitted to intensive care unit
12 secondary outcomes
alpha frequency band energy
Time frame: 24 hours
beta frequency band energy
Time frame: 24 hours
theta frequency band energy
Time frame: 24 hours
delta frequency band energy
Time frame: 24 hours
alpha variability
Time frame: 24 hours
arterial oxygen saturation (SaO2)
Time frame: 24 hours
central venous oxygen saturation (ScvO2)
Time frame: 24 hours
neuron specific enolase (NSE)
Time frame: 24 hours
interleukin-6 (IL-6)
Time frame: 24 hours
troponin i (TNI)
Time frame: 24 hours
high-sensitivity C-reactive protein (hs-CRP)
Time frame: 24 hours
N-terminal pro brain natriuretic peptide (NT-pro-BNP)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Derived from this study: PubMed 39730694Guo Z, Wan W, Liu W, Liu L, Yang Y, Yang C, Cui X. Quantitative electroencephalography predicts postoperative delirium in adult cardiac surgical patients from a prospective observational study. Sci Rep. 2024 Dec 28;14(1):31101. doi: 10.1038/s41598-024-82422-7.
Related trials for Delirium
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The Danish Out-of-Hospital Cardiac Arrest Study
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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.
Liu Wenxue, master principal investigator
Southeast University
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Southeast University, 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 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Liu Wenxue, master (15751866806, diligent_hi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amplitude integrated electroencephalogram (aEEG) (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 NCT03351985, which also lists 1 linked publication.
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 24 Nov 2017.