Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury

Study Overview
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Brief Summary
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To investigate the effect of electroacupuncture on patients with sepsis-associated brain injury.

Official Title
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Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury

Conditions
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Electroacupuncture, Sepsis, Sepsis-associated Brain Injury

Intervention / Treatment
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* Other: electroacupuncture
* Other: shame electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is between 20 and 80 years. Patients meeting the diagnosis of sepsis-associated brain injury. Patients who agreed to accept this trial and signed the informed consent form. Exclusion Criteria: Patients with a history of brain injury, stroke, epilepsy, cognitive impairment, or mental illness prior to admission. Patients who were also involved in any other interventional study. Due to hearing or vision loss, or any other situation that may seriously interfere with study data collection. Patients who refused to participate in this study. The pregnancy test was positive or is currently breastfeeding. Any other situation that the investigator believed might be detrimental to participant in the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroacupuncture<br>The investigators choose Zusanli (ST36) and Baihui (DU20) acupoints to investigate the effect of electroacupuncture on patients with sepsis-associated brain injury. | Other: electroacupuncture<br>* 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.<br>|
| Sham Comparator: shame electroacupuncture<br>The shame electroacupuncture were performed at a shallow depth and 1 mm lateral to Zusanli (ST36) and Baihui (DU20) acupoints. | Other: shame electroacupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuron specific enolase,NSE | Serum index of sepsis-associated brain injury. | Change of NSE from Baseline at 7 days | 
| sTREM2 | Serum index of sepsis-associated brain injury. | Change of sTREM2 from Baseline at 7 days | 
| soluble protein-100β,S100β | Serum index of sepsis-associated brain injury. | Change of S100β from Baseline at 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Physiology and Chronic Health Evaluation，APACHE II | To assess the severity of the disease. | Change of APACHE II from Baseline at 7 days | 
| Glasgow Coma Scale，GCS | To assess the degree of coma. | Change of GCS from Baseline at 7 days | 
| Montreal Cognitive Assessment (MoCA) scale | Rapid screening for cognitive function abnormalities。 | Change of MoCA from Baseline at 7 days |