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Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury

Primary Purpose

Electroacupuncture, Sepsis, Sepsis-associated Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electroacupuncture
shame electroacupuncture
Sponsored by
Tianjin Nankai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Electroacupuncture

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tianjin Nankai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

electroacupuncture

shame electroacupuncture

Arm Description

The investigators choose Zusanli (ST36) and Baihui (DU20) acupoints to investigate the effect of electroacupuncture on patients with sepsis-associated brain injury.

The shame electroacupuncture were performed at a shallow depth and 1 mm lateral to Zusanli (ST36) and Baihui (DU20) acupoints.

Outcomes

Primary Outcome Measures

neuron specific enolase,NSE
Serum index of sepsis-associated brain injury.
sTREM2
Serum index of sepsis-associated brain injury.
soluble protein-100β,S100β
Serum index of sepsis-associated brain injury.

Secondary Outcome Measures

Acute Physiology and Chronic Health Evaluation，APACHE II
To assess the severity of the disease.
Glasgow Coma Scale，GCS
To assess the degree of coma.
Montreal Cognitive Assessment (MoCA) scale
Rapid screening for cognitive function abnormalities。

Full Information

First Posted
October 13, 2021
Last Updated
April 15, 2022
Sponsor
Tianjin Nankai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05171699
Brief Title
Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury
Official Title
Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Nankai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electroacupuncture, Sepsis, Sepsis-associated Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
electroacupuncture
Arm Type
Experimental
Arm Description
The investigators choose Zusanli (ST36) and Baihui (DU20) acupoints to investigate the effect of electroacupuncture on patients with sepsis-associated brain injury.
Arm Title
shame electroacupuncture
Arm Type
Sham Comparator
Arm Description
The shame electroacupuncture were performed at a shallow depth and 1 mm lateral to Zusanli (ST36) and Baihui (DU20) acupoints.
Intervention Type
Other
Intervention Name(s)
electroacupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
shame electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
neuron specific enolase,NSE
Description
Serum index of sepsis-associated brain injury.
Time Frame
Change of NSE from Baseline at 7 days
Title
sTREM2
Description
Serum index of sepsis-associated brain injury.
Time Frame
Change of sTREM2 from Baseline at 7 days
Title
soluble protein-100β,S100β
Description
Serum index of sepsis-associated brain injury.
Time Frame
Change of S100β from Baseline at 7 days
Secondary Outcome Measure Information:
Title
Acute Physiology and Chronic Health Evaluation，APACHE II
Description
To assess the severity of the disease.
Time Frame
Change of APACHE II from Baseline at 7 days
Title
Glasgow Coma Scale，GCS
Description
To assess the degree of coma.
Time Frame
Change of GCS from Baseline at 7 days
Title
Montreal Cognitive Assessment (MoCA) scale
Description
Rapid screening for cognitive function abnormalities。
Time Frame
Change of MoCA from Baseline at 7 days
Other Pre-specified Outcome Measures:
Title
length of stay in hospital
Time Frame
2 months
Title
fatality rate at 28 days after discharge
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianbo Yu, MD
Phone
86-22-27435873
Email
yujianbo11@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianbo Yu, MD
Phone
022-27435873
Email
yujianbo11@126.com
Facility Information:
Facility Name
Tianjin Nankai Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Jianbo, Professor
Phone
（022）27435008
Ext
（022）27435027
Email
yujianbo11@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury

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