Postoperative DeliriumNCT05375409
Evidence for Cognitive Compensation Mechanism in the Postoperative Delirium: a Prospective Multi-modal Neuroimaging Cohort Study in Patients With Frontal Glioma
An observational study of Postoperative Delirium, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
In this study, patients with frontal glioma will be selected for preoperative neurocognitive assessment, APOE genotype detection, 3D structural imaging, cortical blood oxygen level dependent imaging (resting state + task state), and subcortical diffusion tensor multimodal MRI to explore preoperative brain structures… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with frontal glioma on MRI of the head, age 18-60 years
Who may be able to join
- Patients with frontal glioma as revealed by head MRI, aged 18-60 years, with no history of serious disease, and who signed an informed consent form were included in the study. Controls were healthy volunteers of the same age group used for functional MRI resting state data control.
Who cannot join
- (1) patients who cannot cooperate with preoperative neurocognitive assessment and preoperative functional MRI; (2) patients with psychiatric disorders; (3) patients with a history of hydrocephalus, cerebral infarction, or cerebral hemorrhage; (4) patients with epilepsy and a history of antiepileptic drugs; (5) patients who have taken sedative or analgesic drugs within 24 hours of study entry; (6) patients with drug and alcohol abuse; (7) patients with perinatal and lactating conditions; (8) patients with recurrent intracranial tumors; (9) patients with multiple intracranial tumors; (10) patients who have undergone surgery for radiation or chemotherapy; (11) patients with multiple intracranial tumors. (6) patients with drug and alcohol abuse; (7) perinatal and lactating patients; (8) patients with recurrent intracranial tumors; (9) patients with multiple intracranial tumors; (10) patients who have undergone surgery with radiotherapy or chemotherapy; (10) patients with claustrophobia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurosugery, Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Guobin Zhang, MD, +86 13705355517, guobin_0912@sina.com
About this study
Official title: Cognitive Compensation Mechanism in the Postoperative Delirium
In this study, patients with frontal glioma will be selected for preoperative neurocognitive assessment, APOE genotype detection, 3D structural imaging, cortical blood oxygen level dependent imaging (resting state + task state), and subcortical diffusion tensor multimodal MRI to explore preoperative brain structures and brain networks, and postoperative delirium will be assessed 1-3 days after surgery. The aim was to investigate the preoperative neuroanatomical basis of postoperative delirium in this population at the level of brain structure and network connectivity, and to predict the risk of patients by integrating cognitive indicators and neuroimaging markers in an event probability model to construct an optimal sequence of abnormalities in a series of markers, and then to establish a more population-specific subgroup prediction based on different APOE genotypes and the establishment of neurological compensation. The final clinical validation was performed on a small sample to provide a basis for the prevention of postoperative delirium in frontal glioma patients.
Read the detailed description
Delirium is an acute, reversible, widespread alteration of cognitive function characterized by fluctuating cognitive dysfunction, decreased level of consciousness, inattention, disorganized thinking, or disturbed sleep-wake cycles. Postoperative delirium is a common postoperative complication in surgical patients, occurring 1-3 days after surgery and fluctuating between 11-51% depending on the patient's age, type of surgery, and preoperative underlying disease. Postoperative delirium significantly increases perioperative complications and mortality and may leave severe long-term cognitive impairment. However, there is a relative lack of studies addressing delirium after neurosurgical craniotomy. This population may be at high risk for postoperative delirium given the direct impact of intracranial primary lesions on brain structure and function. Our team has completed a prospective cohort study (registry number: NCT03087838) enrolling 800 post-neurosurgical craniotomy patients and found for the first time that patients with gliomas had the highest incidence of postoperative delirium relative to other intracranial occupying lesions at 37.7%, especially frontal gliomas at 53.3%, and that the incidence of delirium was much higher in patients with high-grade gliomas than in patients with low The incidence of delirium was much higher in patients with high-grade gliomas than in patients with low-grade gliomas (50% vs. 16.7%) (the results of the study have not yet been published). Why is the incidence of postoperative delirium higher in patients with gliomas, especially frontal gliomas, than in other lesions, given that they are intracranial occurrences? This question caused us to think about it.
Glioma is the most common intracranial malignancy, accounting for approximately 80% of malignant brain tumors. Recent studies have found that neurocognitive dysfunction is a more common phenomenon in glioma patients and is closely associated with a decrease in health-related quality of life (HRQOL) in patients. Therefore, as the level of glioma treatment improves, patient survival is prolonged, and quality of life is increasingly emphasized, neurocognitive dysfunction has become a hot issue in the field of glioma. Postoperative delirium, as a clear and important "catalyst" for postoperative cognitive dysfunction, deserves more attention.
Given that the treatment of delirium is uncertain and that 30-40% of postoperative delirium is preventable, it is important to screen for high-risk groups. This project will explore the neuroanatomical basis of postoperative delirium in frontal glioma patients using multimodal magnetic resonance technology preoperatively, and integrate neuroimaging features and cognitive events with multidimensional clinical neurocognitive assessment to construct and validate a risk assessment model to predict postoperative delirium in this population. The significance of this study is: (1) to investigate the pathogenesis of postoperative delirium in frontal glioma patients, to explore the objective neuroimaging features with high specificity and sensitivity in vivo, and to provide new ideas and methods for the pathophysiological mechanisms of postoperative delirium; (2) the construction of the prediction model may help to provide early warning of postoperative delirium in glioma patients, which is of great clinical significance for perioperative management.
- Conditions
- Postoperative Delirium
- Keywords
- postoperative delirium, multi-model imaging
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Delirium (+) | Not described | |
| Postoperative Delirium (-) | Not described | |
| Healthy Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrance of postoperative delirium
POD(+) POD(-)
Measured: 1-3day after surgery
preoperative cognitive examination
cognitive scores
Measured: before sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start1 Jan 2019
- Primary completion1 Dec 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375409
- Sponsor's protocol ID
- Guobin Zhang
- Status last verified
- May 2022
- First submitted
- 11 May 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Compensation Mechanism in the Postoperative Delirium
- ClinicalTrials.gov ID
- NCT05375409
- Acronym / sponsor ID
- Guobin Zhang
- Conditions
- Postoperative Delirium
- Keywords
- postoperative delirium, multi-model imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 May 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.
In this study, patients with frontal glioma will be selected for preoperative neurocognitive assessment, APOE genotype detection, 3D structural imaging, cortical blood oxygen level dependent imaging (resting state + task state), and subcortical diffusion tensor multimodal MRI to explore preoperative brain structures and brain networks, and postoperative delirium will be assessed 1-3 days after surgery. The aim was to investigate the preoperative neuroanatomical basis of postoperative delirium in this population at the level of brain structure and network connectivity, and to predict the risk of patients by integrating cognitive indicators and neuroimaging markers in an event probability model to construct an optimal sequence of abnormalities in a series of markers, and then to establish a more population-specific subgroup prediction based on different APOE genotypes and the establishment of neurological compensation. The final clinical validation was performed on a small sample to provide a basis for the prevention of postoperative delirium in frontal glioma patients.
Detailed description
Delirium is an acute, reversible, widespread alteration of cognitive function characterized by fluctuating cognitive dysfunction, decreased level of consciousness, inattention, disorganized thinking, or disturbed sleep-wake cycles. Postoperative delirium is a common postoperative complication in surgical patients, occurring 1-3 days after surgery and fluctuating between 11-51% depending on the patient's age, type of surgery, and preoperative underlying disease. Postoperative delirium significantly increases perioperative complications and mortality and may leave severe long-term cognitive impairment. However, there is a relative lack of studies addressing delirium after neurosurgical craniotomy. This population may be at high risk for postoperative delirium given the direct impact of intracranial primary lesions on brain structure and function. Our team has completed a prospective cohort study (registry number: NCT03087838) enrolling 800 post-neurosurgical craniotomy patients and found for the first time that patients with gliomas had the highest incidence of postoperative delirium relative to other intracranial occupying lesions at 37.7%, especially frontal gliomas at 53.3%, and that the incidence of delirium was much higher in patients with high-grade gliomas than in patients with low The incidence of delirium was much higher in patients with high-grade gliomas than in patients with low-grade gliomas (50% vs. 16.7%) (the results of the study have not yet been published). Why is the incidence of postoperative delirium higher in patients with gliomas, especially frontal gliomas, than in other lesions, given that they are intracranial occurrences? This question caused us to think about it.
Glioma is the most common intracranial malignancy, accounting for approximately 80% of malignant brain tumors. Recent studies have found that neurocognitive dysfunction is a more common phenomenon in glioma patients and is closely associated with a decrease in health-related quality of life (HRQOL) in patients. Therefore, as the level of glioma treatment improves, patient survival is prolonged, and quality of life is increasingly emphasized, neurocognitive dysfunction has become a hot issue in the field of glioma. Postoperative delirium, as a clear and important "catalyst" for postoperative cognitive dysfunction, deserves more attention.
Given that the treatment of delirium is uncertain and that 30-40% of postoperative delirium is preventable, it is important to screen for high-risk groups. This project will explore the neuroanatomical basis of postoperative delirium in frontal glioma patients using multimodal magnetic resonance technology preoperatively, and integrate neuroimaging features and cognitive events with multidimensional clinical neurocognitive assessment to construct and validate a risk assessment model to predict postoperative delirium in this population. The significance of this study is: (1) to investigate the pathogenesis of postoperative delirium in frontal glioma patients, to explore the objective neuroimaging features with high specificity and sensitivity in vivo, and to provide new ideas and methods for the pathophysiological mechanisms of postoperative delirium; (2) the construction of the prediction model may help to provide early warning of postoperative delirium in glioma patients, which is of great clinical significance for perioperative management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Postoperative Delirium (+) | – | – |
| Postoperative Delirium (-) | – | – |
| Healthy Control | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with frontal glioma on MRI of the head, age 18-60 years
Key inclusion criteria (1 listed)
- Patients with frontal glioma as revealed by head MRI, aged 18-60 years, with no history of serious disease, and who signed an informed consent form were included in the study. Controls were healthy volunteers of the same age group used for functional MRI resting state data control.
Key exclusion criteria (1 listed)
- (1) patients who cannot cooperate with preoperative neurocognitive assessment and preoperative functional MRI; (2) patients with psychiatric disorders; (3) patients with a history of hydrocephalus, cerebral infarction, or cerebral hemorrhage; (4) patients with epilepsy and a history of antiepileptic drugs; (5) patients who have taken sedative or analgesic drugs within 24 hours of study entry; (6) patients with drug and alcohol abuse; (7) patients with perinatal and lactating conditions; (8) patients with recurrent intracranial tumors; (9) patients with multiple intracranial tumors; (10) patients who have undergone surgery for radiation or chemotherapy; (11) patients with multiple intracranial tumors. (6) patients with drug and alcohol abuse; (7) perinatal and lactating patients; (8) patients with recurrent intracranial tumors; (9) patients with multiple intracranial tumors; (10) patients who have undergone surgery with radiotherapy or chemotherapy; (10) patients with claustrophobia.
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
occurrance of postoperative delirium
Time frame: 1-3day after surgery
POD(+) POD(-)
preoperative cognitive examination
Time frame: before sugery
cognitive scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- 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.
Department of Neurosugery, Beijing Tiantan Hospital
Beijing, China
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 Postoperative Delirium, run by Beijing Tiantan 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: status not confirmed, as of the sponsor's last update on 16 May 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrance of postoperative delirium (time frame: 1-3day after surgery). The study lists 2 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 16 May 2022.