Electroacupuncture, Sepsis, Sepsis-associated Brain Injury
Conditions
Brief summary
To investigate the effect of electroacupuncture on patients with sepsis-associated brain injury.
Interventions
OTHERelectroacupuncture
The patients in Group EA received electroacupuncture at Zusanli (ST36) (located 5 mm below the head of the inferior fibula and 2 mm lateral to the anterior tibial tuberosity) and Baihui (DU20) (located in the midpoint of the parietal bone) acupoints, the stainless steel acupuncture needles were connected to a Hans acupoint nerve stimulator and inserted into the acupoints.
OTHERshame electroacupuncture
The patients in Group SEA received electroacupuncture at a shallow depth and 1 mm lateral to Zusanli (ST36) (located 5 mm below the head of the inferior fibula and 2 mm lateral to the anterior tibial tuberosity) and Baihui (DU20) (located in the midpoint of the parietal bone) acupoints, the stainless steel acupuncture needles were connected to a Hans acupoint nerve stimulator and inserted into the acupoints.
Sponsors
Tianjin Nankai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age is between 20 and 80 years. 2. Patients meeting the diagnosis of sepsis-associated brain injury. 3. Patients who agreed to accept this trial and signed the informed consent form.
Exclusion criteria
1. Patients with a history of brain injury, stroke, epilepsy, cognitive impairment, or mental illness prior to admission. 2. Patients who were also involved in any other interventional study. 3. Due to hearing or vision loss, or any other situation that may seriously interfere with study data collection. 4. Patients who refused to participate in this study. 5. The pregnancy test was positive or is currently breastfeeding. 6. Any other situation that the investigator believed might be detrimental to participant in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| soluble protein-100β,S100β | Change of S100β from Baseline at 7 days | Serum index of sepsis-associated brain injury. |
| sTREM2 | Change of sTREM2 from Baseline at 7 days | Serum index of sepsis-associated brain injury. |
| neuron specific enolase,NSE | Change of NSE from Baseline at 7 days | Serum index of sepsis-associated brain injury. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) scale | Change of MoCA from Baseline at 7 days | Rapid screening for cognitive function abnormalities。 |
| Acute Physiology and Chronic Health Evaluation，APACHE II | Change of APACHE II from Baseline at 7 days | To assess the severity of the disease. |
| Glasgow Coma Scale，GCS | Change of GCS from Baseline at 7 days | To assess the degree of coma. |
Other
| Measure | Time frame |
|---|---|
| length of stay in hospital | 2 months |
| fatality rate at 28 days after discharge | 2 months |
Countries
China
Contacts
Primary ContactJianbo Yu, MD
Backup ContactJianbo Yu, MD
Outcome results
None listed