Clinical trial NCT04230447: Establishment of a Cohort of Patients With Sepsis-associated Encephalopathy (SAE)
Official title: Peking Union Medical College Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis-Associated Encephalopathy
Keywords: Sepsis-associated encephalopathy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Meet the above three categories of patients consistent with inclusion and exclusion criteria

Brief 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. 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.

Eligibility criteria: Inclusion criteria:

1. sepsis 3.0 diagnostic criteria;
2. Estimated length of hospital stay\> 24h;
3. ages 18-89;
4. Acute brain dysfunction: delirium, coma, epilepsy, focal neurological deficit;
5. Patients who meet the non-infectious SIRS diagnostic criteria

Exclusion criteria:

1. Diagnosis of patients with brain injury before admission, including Alzheimer's disease, craniocerebral injury, etc .;
2. Primary brain injury (cerebral hemorrhage, cerebral infarction, etc.), secondary brain injury (liver brain, lung brain, uremia encephalopathy, pancreatic encephalopathy, metabolic encephalopathy, Wake encephalopathy, etc.);
3. pregnant and lactating women;
4. Those who have undergone bypass surgery in the past 3 months;
5. Hearing and vision impairment;
6. mental illness and melanoma;
7. Abnormal coagulation, active bleeding
8. Patients with infection at lumbar puncture site
9. Meningeal leukemia patients
10. Patients with other types of encephalopathy

Primary outcomes:
measure: Finding the pathogenesis of sepsis encephalopathy
timeFrame: 2020-2030
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing Shi
Study officials:
References: