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NCT Number: NCT04230447

Establishment of a Cohort of Patients With Sepsis-associated Encephalopathy (SAE)

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • Abnormal coagulation, active bleeding
  • Patients with infection at lumbar puncture site
  • Meningeal leukemia patients
  • Patients with other types of encephalopathy

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Li, Medical PhD

CONTACT

[email protected]

86-0-13693109826

Sponsors and collaborators

Lead sponsor

Yi Li, MD

Other

Registry information

Official study title

Peking Union Medical College Hospital

Acronym: SAE

Important dates

Study start
2021
Primary completion
2026
Study completion
2030
First posted
Jan 18, 2020
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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