ElectroacupunctureNCT05171699
Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury
A study testing electroacupuncture in people with Electroacupuncture and Sepsis, run by Tianjin Nankai Hospital at 1 site in China.
Trial summary
To investigate the effect of electroacupuncture on patients with sepsis-associated brain injury. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Electroacupuncture, Sepsis, Sepsis-associated Brain Injury
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, 300000
Yu Jianbo, Professor, （022）27435008 ext. （022）27435027, yujianbo11@126.com
About this study
To investigate the effect of electroacupuncture on patients with sepsis-associated brain injury.
- Conditions
- Electroacupuncture, Sepsis, Sepsis-associated Brain Injury
- Being tested
- electroacupuncture, shame electroacupuncture
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
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 electroacupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture | Experimental | The investigators choose Zusanli (ST36) and Baihui (DU20) acupoints to investigate the effect of electroacupuncture on patients with sepsis-associated brain injury. Receives: 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. Receives: Other: shame electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuron specific enolase,NSE
Serum index of sepsis-associated brain injury.
Measured: Change of NSE from Baseline at 7 days
sTREM2
Serum index of sepsis-associated brain injury.
Measured: Change of sTREM2 from Baseline at 7 days
soluble protein-100β,S100β
Serum index of sepsis-associated brain injury.
Measured: Change of S100β from Baseline at 7 days
Secondary outcomes (3)
Acute Physiology and Chronic Health Evaluation，APACHE II
To assess the severity of the disease.
Measured: Change of APACHE II from Baseline at 7 days
Glasgow Coma Scale，GCS
To assess the degree of coma.
Measured: Change of GCS from Baseline at 7 days
Montreal Cognitive Assessment (MoCA) scale
Rapid screening for cognitive function abnormalities。
Measured: Change of MoCA from Baseline at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start25 Apr 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroacupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Nankai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianbo Yu, Tianjin Nankai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171699
- Sponsor's protocol ID
- NKYY-EA-SAE
- Status last verified
- Apr 2022
- First submitted
- 13 Oct 2021
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture in Patients With Sepsis Associated Brain Injury
- ClinicalTrials.gov ID
- NCT05171699
- Acronym / sponsor ID
- NKYY-EA-SAE
- Conditions
- Electroacupuncture, Sepsis, Sepsis-associated Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tianjin Nankai HospitalUniversity, hospital or other
- Study start
- 25 Apr 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of electroacupuncture on patients with sepsis-associated brain injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture | Experimental | Other: electroacupunctureThe investigators choose Zusanli (ST36) and Baihui (DU20) acupoints to investigate the effect of electroacupuncture on patients with sepsis-associated brain injury. |
| shame electroacupuncture | Sham comparator | Other: shame electroacupunctureThe shame electroacupuncture were performed at a shallow depth and 1 mm lateral to Zusanli (ST36) and Baihui (DU20) acupoints. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupunctureThe 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. | Other | electroacupuncture |
| shame electroacupunctureThe 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. | Other | shame electroacupuncture |
Primary outcome
neuron specific enolase,NSE
Time frame: Change of NSE from Baseline at 7 days
Serum index of sepsis-associated brain injury.
sTREM2
Time frame: Change of sTREM2 from Baseline at 7 days
Serum index of sepsis-associated brain injury.
soluble protein-100β,S100β
Time frame: Change of S100β from Baseline at 7 days
Serum index of sepsis-associated brain injury.
3 secondary outcomes
Acute Physiology and Chronic Health Evaluation，APACHE II
Time frame: Change of APACHE II from Baseline at 7 days
Glasgow Coma Scale，GCS
Time frame: Change of GCS from Baseline at 7 days
Montreal Cognitive Assessment (MoCA) scale
Time frame: Change of MoCA from Baseline at 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Electroacupuncture and Sepsis, run by Tianjin Nankai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianbo Yu, MD (86-22-27435873, yujianbo11@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuron specific enolase,NSE (time frame: Change of NSE from Baseline at 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.