Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury

NCT ID: NCT05171699

Last Updated: 2022-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2022-12-30

Brief Summary

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

Detailed Description

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Conditions

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Electroacupuncture Sepsis Sepsis-associated Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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electroacupuncture

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

Group Type EXPERIMENTAL

electroacupuncture

Intervention Type OTHER

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 electroacupuncture

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

Group Type SHAM_COMPARATOR

shame electroacupuncture

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Nankai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jianbo Yu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianbo Yu, MD

Role: CONTACT

86-22-27435873

Jianbo Yu, MD

Role: CONTACT

022-27435873

Facility Contacts

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Yu Jianbo, Professor

Role: primary

(022)27435008 ext. (022)27435027

Other Identifiers

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NKYY-EA-SAE

Identifier Type: -

Identifier Source: org_study_id

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