Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury

NCT05171699 | Unknown DMC

• 1 other identifier: NKYY-EA-SAE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Electroacupuncture; Sepsis; Sepsis-associated Brain Injury

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Acute Physiology and Chronic Health Evaluation，APACHE II

  Change of APACHE II from Baseline at 7 days

• Glasgow Coma Scale，GCS

  Change of GCS from Baseline at 7 days

• Montreal Cognitive Assessment (MoCA) scale

  Change of MoCA from Baseline at 7 days

Other Outcomes (2)

• length of stay in hospital

  2 months

• fatality rate at 28 days after discharge

  2 months

Study Arms (2)

electroacupuncture

EXPERIMENTAL

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

Other: electroacupuncture

shame electroacupuncture

SHAM COMPARATOR

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

Other: shame electroacupuncture

Interventions

electroacupuncture 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.

electroacupuncture

shame electroacupuncture 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.

shame electroacupuncture

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Nankai Hospital: lead

Study Sites (1)

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Jianbo Yu, MD

CONTACT

86-22-27435873; yujianbo11@126.com

Jianbo Yu, MD

CONTACT

022-27435873; yujianbo11@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: December 29, 2021
• Study Start: April 25, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)