Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury

N/AUnknownNCT05171699

Tianjin Nankai Hospital40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Electroacupuncture Sepsis Sepsis-associated Brain Injury

Interventions

electroacupunctureOTHER

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.

shame electroacupunctureOTHER

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Outcomes

Primary Outcomes

neuron specific enolase,NSE

Serum index of sepsis-associated brain injury.

Time frame: Change of NSE from Baseline at 7 days

sTREM2

Serum index of sepsis-associated brain injury.

Time frame: Change of sTREM2 from Baseline at 7 days

soluble protein-100β,S100β

Serum index of sepsis-associated brain injury.

Time frame: Change of S100β from Baseline at 7 days

Secondary Outcomes

Acute Physiology and Chronic Health Evaluation，APACHE II

To assess the severity of the disease.

Time frame: Change of APACHE II from Baseline at 7 days

Glasgow Coma Scale，GCS

To assess the degree of coma.

Time frame: Change of GCS from Baseline at 7 days

Montreal Cognitive Assessment (MoCA) scale

Rapid screening for cognitive function abnormalities。

Time frame: Change of MoCA from Baseline at 7 days

Central Contacts

Jianbo Yu, MD

CONTACT

86-22-27435873 yujianbo11@126.com

Jianbo Yu, MD

CONTACT

022-27435873 yujianbo11@126.com

Data from ClinicalTrials.gov

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