Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury

Not Applicable

• Conditions: Sepsis; Electroacupuncture; Sepsis-associated Brain Injury
• Interventions: Other: shame electroacupuncture; Other: electroacupuncture

• Registration Number: NCT05171699
• Lead Sponsor: Tianjin Nankai Hospital

Brief Summary

To investigate the effect of electroacupuncture on patients with sepsis-associated brain injury.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2021-12-29
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-15
• Study Start: 2022-04-25
• Last Update Posted: 2022-04-25
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
shame electroacupuncture	shame electroacupuncture	The shame electroacupuncture were performed at a shallow depth and 1 mm lateral to Zusanli (ST36) and Baihui (DU20) acupoints.
electroacupuncture	electroacupuncture	The investigators choose Zusanli (ST36) and Baihui (DU20) acupoints to investigate the effect of electroacupuncture on patients with sepsis-associated brain injury.

Primary Outcome Measures

Name	Time	Method
neuron specific enolase,NSE	Change of NSE 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.
soluble protein-100β,S100β	Change of S100β from Baseline at 7 days	Serum index of sepsis-associated brain injury.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tianjin Nankai Hospital; 🇨🇳 Tianjin, Tianjin, China