Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury

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

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Electroacupuncture; Sepsis-associated Brain Injury
• Intervention / Treatment: Other: electroacupuncture; Other: shame electroacupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianbo Yu, MD; Phone Number: 022-27435873; Email: yujianbo11@126.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Recruiting
      • Tianjin Nankai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
length of stay in hospital	2 months
fatality rate at 28 days after discharge	2 months

Collaborators and Investigators

• Sponsor: Tianjin Nankai Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 25, 2022
• Primary Completion (ANTICIPATED): December 30, 2022
• Study Completion (ANTICIPATED): December 30, 2022

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (ACTUAL): December 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Craniocerebral Trauma; Trauma, Nervous System; Sepsis; Toxemia; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: NKYY-EA-SAE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No