Sepsis-Associated EncephalopathySAENCT04230447
Establishment of a Cohort of Patients With Sepsis-associated Encephalopathy (SAE)
An observational study of Sepsis-Associated Encephalopathy, run by Yi Li, MD at 1 site in China.
Trial summary
In this study, the researcher involved the sepsis patients(defined by sepsis 3.0) in Peking Union Medical College Hospital. The SAE was defined as the Glasgow Coma Scale (GCS) score of less than 15 and the Non-SAE group GCS = 15. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Sepsis-Associated Encephalopathy
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 14 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Meet the above three categories of patients consistent with inclusion and exclusion criteria
Who may be able to join
- sepsis 3.0 diagnostic criteria;
- Estimated length of hospital stay> 24h;
- ages 18-89;
- Acute brain dysfunction: delirium, coma, epilepsy, focal neurological deficit;
- Patients who meet the non-infectious SIRS diagnostic criteria
Who cannot join
- Diagnosis of patients with brain injury before admission, including Alzheimer's disease, craniocerebral injury, etc .;
- Primary brain injury (cerebral hemorrhage, cerebral infarction, etc.), secondary brain injury (liver brain, lung brain, uremia encephalopathy, pancreatic encephalopathy, metabolic encephalopathy, Wake encephalopathy, etc.);
- pregnant and lactating women;
- Those who have undergone bypass surgery in the past 3 months;
- Hearing and vision impairment;
- mental illness and melanoma;
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- Abnormal coagulation, active bleeding
- Patients with infection at lumbar puncture site
- Meningeal leukemia patients
- Patients with other types of encephalopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yi Li, 13693109826, billliyi@126.com
About this study
Official title: Peking Union Medical College Hospital
In this study, the researcher involved the sepsis patients(defined by sepsis 3.0) in Peking Union Medical College Hospital. The SAE was defined as the Glasgow Coma Scale (GCS) score of less than 15 and the Non-SAE group GCS = 15. The control group was the non-infectious patients with acute disease strikes and the healthy control. After the sample collection, the RNA-sequence, metabolites and cytokines were under detection.
Read the detailed description
We conducted a prospective observational cohort study of critically ill patients admitted to Emergency Department at a tertiary care hospital. This clinical study was approved by the Ethics Institutional Review Board of Peking Union Medical College Hospital. We identified the sepsis patients according to the Sepsis 3.0 criteria. The SAE was defined as the Glasgow Coma Scale (GCS) score of less than 15 and the Non-SAE group GCS = 15. The control group was the non-infectious patients with acute disease strikes and the healthy control.
We are collecting the samples of the included participants, including whole blood, plasma, serum, cerebrospinal fluid, stool and rectal swabs. The total RNA was extracted from the whole blood by PAXgene Blood RNA MDx kit (PreAnalytiX) for RNA sequence. We used the Ultra-high performance liquid chromatography-MS/MS (UHPLC-MS/MS) analysis for detected metabolites.
We used the Bio-Plex 200 system (Luminex Corporation, Austin, TX, USA) and Simoa HD-X AnalyzerTM (Quanterix) platform to detect cytokines.
- Conditions
- Sepsis-Associated Encephalopathy
- Being tested
- No intervention
- Keywords
- Sepsis-associated encephalopathy
- Medical subject headings
- Sepsis-Associated Encephalopathy
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 |
|---|---|---|
| sepsis associated encephalopathy (SAE) | This study is an observational study without drug and other interventions The SAE was defined as the Glasgow Coma Scale (GCS) score of less than 15 Receives: Other: No intervention | |
| Non-SAE | This study is an observational study without drug and other interventions Non-SAE group GCS = 15 Receives: Other: No intervention | |
| Control | This study is an observational study without drug and other interventions The control group was the emergency department patients with acute disease strikes, including heart attack, infraction, and healthy control. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finding the pathogenesis of sepsis encephalopathy
To find the pathogenesis of sepsis encephalopathy by genetic testing of blood and cerebrospinal fluid in patients with sepsis and sepsis and SIRS by molecular biomarkers and physiological parameters
Measured: 2020-2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Feb 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion14 Jan 2030 (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 Sepsis-Associated EncephalopathyStudies 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Li, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Li, MD, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230447
- Sponsor's protocol ID
- ZS-2165
- Acronym
- SAE
- Status last verified
- Jun 2023
- First submitted
- 9 Jan 2020
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qin M, Yu S, Lu X, Gong C, Song Z, Zhu H, Gao Y, Li Y. Reduced phosphatidylcholine and phosphatidylethanolamine levels correlate with inflammatory activation in sepsis-associated encephalopathy. Eur J Med Res. 2025 Aug 31;30(1):828. doi: 10.1186/s40001-025-03115-z.
PubMed 40887666
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking Union Medical College Hospital
- ClinicalTrials.gov ID
- NCT04230447
- Acronym / sponsor ID
- SAE / ZS-2165
- Conditions
- Sepsis-Associated Encephalopathy
- Keywords
- Sepsis-associated encephalopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Yi Li, MDUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 14 Jan 2030 (estimated)
- First posted
- 18 Jan 2020 (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, the researcher involved the sepsis patients(defined by sepsis 3.0) in Peking Union Medical College Hospital. The SAE was defined as the Glasgow Coma Scale (GCS) score of less than 15 and the Non-SAE group GCS = 15. The control group was the non-infectious patients with acute disease strikes and the healthy control. After the sample collection, the RNA-sequence, metabolites and cytokines were under detection.
Detailed description
We conducted a prospective observational cohort study of critically ill patients admitted to Emergency Department at a tertiary care hospital. This clinical study was approved by the Ethics Institutional Review Board of Peking Union Medical College Hospital. We identified the sepsis patients according to the Sepsis 3.0 criteria. The SAE was defined as the Glasgow Coma Scale (GCS) score of less than 15 and the Non-SAE group GCS = 15. The control group was the non-infectious patients with acute disease strikes and the healthy control.
We are collecting the samples of the included participants, including whole blood, plasma, serum, cerebrospinal fluid, stool and rectal swabs. The total RNA was extracted from the whole blood by PAXgene Blood RNA MDx kit (PreAnalytiX) for RNA sequence. We used the Ultra-high performance liquid chromatography-MS/MS (UHPLC-MS/MS) analysis for detected metabolites.
We used the Bio-Plex 200 system (Luminex Corporation, Austin, TX, USA) and Simoa HD-X AnalyzerTM (Quanterix) platform to detect cytokines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sepsis associated encephalopathy (SAE) | – | Other: No interventionThis study is an observational study without drug and other interventions The SAE was defined as the Glasgow Coma Scale (GCS) score of less than 15 |
| Non-SAE | – | Other: No interventionThis study is an observational study without drug and other interventions Non-SAE group GCS = 15 |
| Control | – | Other: No interventionThis study is an observational study without drug and other interventions The control group was the emergency department patients with acute disease strikes, including heart attack, infraction, and healthy control. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Meet the above three categories of patients consistent with inclusion and exclusion criteria
Key inclusion criteria (5 listed)
- sepsis 3.0 diagnostic criteria;
- Estimated length of hospital stay> 24h;
- ages 18-89;
- Acute brain dysfunction: delirium, coma, epilepsy, focal neurological deficit;
- Patients who meet the non-infectious SIRS diagnostic criteria
Key exclusion criteria (10 listed)
- Diagnosis of patients with brain injury before admission, including Alzheimer's disease, craniocerebral injury, etc .;
- Primary brain injury (cerebral hemorrhage, cerebral infarction, etc.), secondary brain injury (liver brain, lung brain, uremia encephalopathy, pancreatic encephalopathy, metabolic encephalopathy, Wake encephalopathy, etc.);
- pregnant and lactating women;
- Those who have undergone bypass surgery in the past 3 months;
- Hearing and vision impairment;
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 | Control, Non-SAE, sepsis associated encephalopathy (SAE) |
Primary outcome
Finding the pathogenesis of sepsis encephalopathy
Time frame: 2020-2030
To find the pathogenesis of sepsis encephalopathy by genetic testing of blood and cerebrospinal fluid in patients with sepsis and sepsis and SIRS by molecular biomarkers and physiological parameters
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Derived from this study: PubMed 40887666Qin M, Yu S, Lu X, Gong C, Song Z, Zhu H, Gao Y, Li Y. Reduced phosphatidylcholine and phosphatidylethanolamine levels correlate with inflammatory activation in sepsis-associated encephalopathy. Eur J Med Res. 2025 Aug 31;30(1):828. doi: 10.1186/s40001-025-03115-z.
- Individual participant dataSharing planned: No
Related trials for Sepsis-Associated Encephalopathy
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Sepsis Associated Encephalopathy (SAE) Biomarkers
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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.
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 Sepsis-Associated Encephalopathy, run by Yi Li, MD 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 Jun 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Li, Medical PhD (86-0-13693109826, billliyi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finding the pathogenesis of sepsis encephalopathy (time frame: 2020-2030). 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 NCT04230447, 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 15 Jun 2023.