Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury

Sepsis Clinical Trial

Official title:

Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05171699
• Other study ID #: NKYY-EA-SAE
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2022
• Source: Tianjin Nankai Hospital
• Contact: Jianbo Yu, MD
• Phone: 86-22-27435873
• Email: yujianbo11[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Electroacupuncture
• Sepsis
• Toxemia
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Tianjin Nankai Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	length of stay in hospital		2 months
Other	fatality rate at 28 days after discharge		2 months
Primary	neuron specific enolase,NSE	Serum index of sepsis-associated brain injury.	Change of NSE from Baseline at 7 days
Primary	sTREM2	Serum index of sepsis-associated brain injury.	Change of sTREM2 from Baseline at 7 days
Primary	soluble protein-100ß,S100ß	Serum index of sepsis-associated brain injury.	Change of S100ß from Baseline at 7 days
Secondary	Acute Physiology and Chronic Health Evaluation,APACHE II	To assess the severity of the disease.	Change of APACHE II from Baseline at 7 days
Secondary	Glasgow Coma Scale,GCS	To assess the degree of coma.	Change of GCS from Baseline at 7 days
Secondary	Montreal Cognitive Assessment (MoCA) scale	Rapid screening for cognitive function abnormalities?	Change of MoCA from Baseline at 7 days