Acute Respiratory Distress SyndromeNCT06278675
Multiple Study of Electroaccpuncture in ARDS
A study testing Acupuncture needles in people with Acute Respiratory Distress Syndrome and Sepsis, run by Nanjing University of Traditional Chinese Medicine at 1 site in China.
Trial summary
In order to clarify the clinical efficacy of electroacupuncture on inhibiting systemic inflammatory response, improving respiratory mechanics parameters and prognosis in patients with sepsis-related ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Sepsis
- What is being tested?
- Acupuncture needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of the Surviving Sepsis Campaign: Updated International Guidelines for the Treatment of Sepsis and Septic Shock 2021
- Meet the diagnostic criteria of the European Society of Critical Care Medicine (ESICM) Guidelines for Acute Respiratory Distress Syndrome: Definition, Phenotype and Respiratory Support Strategies
- Age >18 years
- Expected duration of mechanical ventilation>48 hours
- Expected ICU stay of more than 7 days
- Signed informed consent.
Who cannot join
- Participated in other clinical trials
- Pregnant, lactating or miscarriage
- Patients with disseminated tumors or tumors receiving chemotherapy and other special treatments
- Alcohol abuse
- Severe cardiovascular, brain, liver, kidney, psychiatric diseases, diabetes, multiple system atrophy, cauda equina injury or myelopathy
- Systolic blood pressure < 90mmHg within 2 hours before the start of the study
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- Severe burns or severe skin diseases
- Pacemaker placement, metal allergy or severe needle sickness
- Abnormal coagulation function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, 210029
Jun Lu, Doctor, +86 13813865758, lujun@njucm.edu.cn
About this study
Official title: A Multicenter Clinical Study on the Effect of Electroacupuncture on the Mechanical Ventilation Strategy in Patients With Sepsis-related ARDS
In order to clarify the clinical efficacy of electroacupuncture on inhibiting systemic inflammatory response, improving respiratory mechanics parameters and prognosis in patients with sepsis-related ARDS.
- Conditions
- Acute Respiratory Distress Syndrome, Sepsis
- Being tested
- Acupuncture needles
- Medical subject headings
- Respiratory Distress Syndrome, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture needlesDevice
- Experimental group: Sterile stainless steel needle electroacupuncture treatment was applied, and the acupuncture points were as follows: bilateral Zusanli (ST36), Neiguan (PC6), Hegu (LI4), Shaoshang (LU11), and Feng Long (ST40). 1 time a day, 30 minutes each time, for 7 days.
- Control group: Placebo needles were applied, and the acupuncture points were as follows: bilateral Zusanli (ST36), Neiguan (PC6), Hegu (LI4), Shaoshang (LU11), and Feng Long (ST40). 1 time a day, 30 minutes each time, for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group: Sterile stainless steel needle electroacupuncture treatment was applied, and the acupuncture points were as follows: bilateral Zusanli (ST36), Neiguan (PC6), Hegu (LI4), Shaoshang (LU11), and Feng Long (ST40). 1 time a day, 30 minutes each time, for 7 days. Receives: Device: Acupuncture needles |
| Control group | No intervention | Control group: Placebo needles were applied, and the acupuncture points were as follows: bilateral Zusanli (ST36), Neiguan (PC6), Hegu (LI4), Shaoshang (LU11), and Feng Long (ST40). 1 time a day, 30 minutes each time, for 7 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory mechanics indicators 1
Oxygenation index(P/F)
Measured: Day 0、day 7
Respiratory mechanics indicators 2
Respiratory rate(RR)
Measured: Day 0、day 7
Respiratory mechanics indicators 3
Driving pressure(DP)
Measured: Day 0、day 7
Respiratory mechanics indicators 4
Positive end expiratory pressure(PEEP)
Measured: Day 0、day 7
Respiratory mechanics indicators 5
Mechanical ventilation days(MV days)
Measured: Day 0、day 7
Respiratory mechanics indicators 6
Mechanical ventilation free days(MV free days)
Measured: Day 0、day 7
Respiratory mechanics indicators 7
Extubation situation
Measured: Day 0、day 7
Secondary outcomes (12)
Sedation and analgesia
RASS score
Measured: Day 0、day 7
Sedative drug use
The dose and duration of sedative medication will be recorded.
Measured: Day 0、day 7
Analgesic drug use
The dose and duration of analgesic medication will be recorded.
Measured: Day 0、day 7
Inflammatory factors
IL-1β、IL-6、IL-2、IL-4、IL-5、IL-8、IL-10、IL-17、IL-12、 IFN-γ、IFN-α、TNF-α.
Measured: Day 0、day 7
CD4、CD8、CD4/CD8
Flow cytometry will be used to detect serum CD4, CD8 and CD4/CD8 levels.
Measured: Day 0、day 7
Vasoactive drugs applications
The duration of vasoactive drug use will be recorded.
Measured: Day 0 to day 7
CRRT applications
The duration of continuous renal replacement therapy will be recorded.
Measured: Day 0 to day 7
ECMO applications
The duration of extracorporeal membrane oxygenation will be recorded.
Measured: Day 0 to day 7
All-cause mortality to day 28
The prognosis of patients on the 28th days will be counted.
Measured: Up to 28 days
All-cause mortality to day 60
The prognosis of patients on the 60th days will be counted.
Measured: Up to 60 days
ICU-free days
The prognosis of patients ICU length of stay will be counted.
Measured: 2 year
Hospital-free days
The prognosis of patients total length of stay will be counted.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start10 May 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Lu, MD, Nanjing University of Traditional Chinese Medicine
- Investigators
- Jun Lu, Doctor, Principal investigator, Jiangsu Province Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278675
- Sponsor's protocol ID
- SEOVA
- Status last verified
- Apr 2024
- First submitted
- 12 Feb 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study on the Effect of Electroacupuncture on the Mechanical Ventilation Strategy in Patients With Sepsis-related ARDS
- ClinicalTrials.gov ID
- NCT06278675
- Acronym / sponsor ID
- SEOVA
- Conditions
- Acute Respiratory Distress Syndrome, Sepsis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Nanjing University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 10 May 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Feb 2024 (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.
In order to clarify the clinical efficacy of electroacupuncture on inhibiting systemic inflammatory response, improving respiratory mechanics parameters and prognosis in patients with sepsis-related ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Acupuncture needlesExperimental group: Sterile stainless steel needle electroacupuncture treatment was applied, and the acupuncture points were as follows: bilateral Zusanli (ST36), Neiguan (PC6), Hegu (LI4), Shaoshang (LU11), and Feng Long (ST40). 1 time a day, 30 minutes each time, for 7 days. |
| Control group | No intervention | –Control group: Placebo needles were applied, and the acupuncture points were as follows: bilateral Zusanli (ST36), Neiguan (PC6), Hegu (LI4), Shaoshang (LU11), and Feng Long (ST40). 1 time a day, 30 minutes each time, for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet the diagnostic criteria of the Surviving Sepsis Campaign: Updated International Guidelines for the Treatment of Sepsis and Septic Shock 2021
- Meet the diagnostic criteria of the European Society of Critical Care Medicine (ESICM) Guidelines for Acute Respiratory Distress Syndrome: Definition, Phenotype and Respiratory Support Strategies
- Age >18 years
- Expected duration of mechanical ventilation>48 hours
- Expected ICU stay of more than 7 days
Key exclusion criteria (9 listed)
- Participated in other clinical trials
- Pregnant, lactating or miscarriage
- Patients with disseminated tumors or tumors receiving chemotherapy and other special treatments
- Alcohol abuse
- Severe cardiovascular, brain, liver, kidney, psychiatric diseases, diabetes, multiple system atrophy, cauda equina injury or myelopathy
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 |
|---|---|---|
| Acupuncture needles1. Experimental group: Sterile stainless steel needle electroacupuncture treatment was applied, and the acupuncture points were as follows: bilateral Zusanli (ST36), Neiguan (PC6), Hegu (LI4), Shaoshang (LU11), and Feng Long (ST40). 1 time a day, 30 minutes each time, for 7 days. 2. Control group: Placebo needles were applied, and the acupuncture points were as follows: bilateral Zusanli (ST36), Neiguan (PC6), Hegu (LI4), Shaoshang (LU11), and Feng Long (ST40). 1 time a day, 30 minutes each time, for 7 days. | Device | Experimental group |
Primary outcome
Respiratory mechanics indicators 1
Time frame: Day 0、day 7
Oxygenation index(P/F)
Respiratory mechanics indicators 2
Time frame: Day 0、day 7
Respiratory rate(RR)
Respiratory mechanics indicators 3
Time frame: Day 0、day 7
Driving pressure(DP)
Respiratory mechanics indicators 4
Time frame: Day 0、day 7
Positive end expiratory pressure(PEEP)
Respiratory mechanics indicators 5
Time frame: Day 0、day 7
Mechanical ventilation days(MV days)
Respiratory mechanics indicators 6
Time frame: Day 0、day 7
Mechanical ventilation free days(MV free days)
Respiratory mechanics indicators 7
Time frame: Day 0、day 7
Extubation situation
12 secondary outcomes
Sedation and analgesia
Time frame: Day 0、day 7
Sedative drug use
Time frame: Day 0、day 7
Analgesic drug use
Time frame: Day 0、day 7
Inflammatory factors
Time frame: Day 0、day 7
CD4、CD8、CD4/CD8
Time frame: Day 0、day 7
Vasoactive drugs applications
Time frame: Day 0 to day 7
CRRT applications
Time frame: Day 0 to day 7
ECMO applications
Time frame: Day 0 to day 7
All-cause mortality to day 28
Time frame: Up to 28 days
All-cause mortality to day 60
Time frame: Up to 60 days
ICU-free days
Time frame: 2 year
Hospital-free days
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- 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.
Jun Lu, Doctor principal investigator
Jiangsu Province Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture needles in people with Acute Respiratory Distress Syndrome and Sepsis, run by Nanjing University of Traditional Chinese Medicine 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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 23 Apr 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Lu, Doctor (+86 13813865758, lujun@njucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory mechanics indicators 1 (time frame: Day 0、day 7). The study lists 7 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 23 Apr 2024.