SepsisNCT06006325
Electroacupuncture Modulates SPMs Metabolism and Respiratory Symptoms in Patients With Sepsis Complicating ARDS
A study testing electroacupuncture treatment in people with Sepsis and Acute Respiratory Distress Syndrome, run by Tianjin Nankai Hospital at 1 site in China.
Trial summary
In this interventional clinical trial, researchers will administer electroacupuncture versus sham electroacupuncture to sepsis patients with ARDS and collect objective outcome measures. The study will be divided into 2 groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Acute Respiratory Distress Syndrome
- What is being tested?
- electroacupuncture treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2023to 2 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females over the age of 18;
- Diagnosis meets SPESIS 3 criteria for sepsis;
- The diagnosis meets the Berlin diagnostic criteria for ARDS;
- ARDS was diagnosed within 48h;
- Capable of understanding the purpose and risk of the study;
- Patients or proxy must give written informed consent before any assessment is performed.
Who cannot join
- ARDS was diagnosed 48h later;
- Pregnancy, lactation or perinatal period;
- malignant tumor;
- Severe liver failure or kidney failure;
- Predicted mortality risk of patients within 24h>80%;
- Severe end-stage lung disease;
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- ECMO patients are undergoing implementation;
- HIV seropositive or Syphilis seropositive;
- Any clinical-relevant condition that might affect study participation and/or study results;
- Participation in any other intervention trial;
- Unwillingness or inability to following the study protocol in the investigators opinion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, 300000
Shuan Dong, Professor, （022）27435008 ext. （022）27435027, dongshuan@126.com
About this study
Official title: Electroacupuncture Modulates the Metabolism of SPMs and Ameliorates Respiratory Symptoms and Inflammation in Patients With Sepsis Complicating ARDS
In this interventional clinical trial, researchers will administer electroacupuncture versus sham electroacupuncture to sepsis patients with ARDS and collect objective outcome measures. The study will be divided into 2 groups. The EA group will receive electroacupuncture and the SHAM-EA group will receive sham electroacupuncture. The purpose of this study is to investigate the effect of electroacupuncture on the synthesis of SPMs in sepsis patients with ARDS.
- Conditions
- Sepsis, Acute Respiratory Distress Syndrome
- Being tested
- electroacupuncture treatment, sham electroacupuncture treatment
- Medical subject headings
- Sepsis, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupuncture treatmentDevice
Patients received acupuncture on both sides of the Zusanli (ST36) acupuncture points, and after "Deqi ", the needle was connected to an electro-acupuncture device (Hwato, Suzhou Medical ). The EA stimulation lasted for 30 min.
sham electroacupuncture treatmentDevice
The participants in the SHAM-EA group performed shallow punctures at the bilateral non-acupuncture points, did not perform the "Deqi" operation, and were connected to the electroacupuncture stimulator but not energized.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture (EA) | Experimental | The acupoints were "Deqi", and the electroacupuncture stimulator was connected and energized. Receives: Device: electroacupuncture treatment |
| Sham electroacupuncture (SHAM-EA) | Sham comparator | No "Deqi" operation was performed on non-acupuncture points, and the electroacupuncture stimulator was connected and not energized. Receives: Device: sham electroacupuncture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of Lipoxin A4 (LXA4)
Serum levels of LXA4 were measured in post-intervention patients and levels were compared to Day 0.
Measured: Up to 7 days
Secondary outcomes (9)
LXA4 levels in BALF
LXA4 levels were measured in the BALF of patients after the intervention and the levels were compared to day 0.
Measured: Up to 7 days
Ventilation-free days
The number of days the patient was alive and free of mechanical ventilation (MV)
Measured: Up to 28 days
Oxygenation index
The ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).
Measured: Up to 7 days
Ventilator-provided positive end-expiratory pressure (PEEP)
Ventilator parameter
Measured: Up to 7 days
plateau pressure
Ventilator parameter
Measured: Up to 7 days
tidal volume
Ventilator parameter
Measured: Up to 7 days
Inflammation biomarkers Inflammation levels
Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6)
Measured: Up to 7 days
Sequential Organ-Failure Assessment (SOFA) score
The SOFA score is used to assess the severity and prognosis of sepsis.SOFA was based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction.
Measured: Up to 7 days
Rate of electroacupuncture-related adverse events
Rate of electroacupuncture-related adverse events
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start20 Aug 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion2 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Care provider
- Enrolment
- 70 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
- Investigators
- Jianbo Yu, MD, Study director, Tianjin Nankai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006325
- Sponsor's protocol ID
- NKYY_YXKT_IRB_2022_023_01
- Status last verified
- Mar 2024
- First submitted
- 16 Aug 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu S, Wang Z, Su Y, Qi L, Yang W, Fu M, Jing X, Wang Y, Ma Q. A neuroanatomical basis for electroacupuncture to drive the vagal-adrenal axis. Nature. 2021 Oct;598(7882):641-645. doi: 10.1038/s41586-021-04001-4. Epub 2021 Oct 13.
PubMed 34646018Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
PubMed 23480440Cecconi M, Evans L, Levy M, Rhodes A. Sepsis and septic shock. Lancet. 2018 Jul 7;392(10141):75-87. doi: 10.1016/S0140-6736(18)30696-2. Epub 2018 Jun 21.
PubMed 29937192Fowler AA 3rd, Truwit JD, Hite RD, Morris PE, DeWilde C, Priday A, Fisher B, Thacker LR 2nd, Natarajan R, Brophy DF, Sculthorpe R, Nanchal R, Syed A, Sturgill J, Martin GS, Sevransky J, Kashiouris M, Hamman S, Egan KF, Hastings A, Spencer W, Tench S, Mehkri O, Bindas J, Duggal A, Graf J, Zellner S, Yanny L, McPolin C, Hollrith T, Kramer D, Ojielo C, Damm T, Cassity E, Wieliczko A, Halquist M. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019 Oct 1;322(13):1261-1270. doi: 10.1001/jama.2019.11825.
PubMed 31573637
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture Modulates the Metabolism of SPMs and Ameliorates Respiratory Symptoms and Inflammation in Patients With Sepsis Complicating ARDS
- ClinicalTrials.gov ID
- NCT06006325
- Acronym / sponsor ID
- NKYY_YXKT_IRB_2022_023_01
- Conditions
- Sepsis, Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tianjin Nankai HospitalUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 2 Oct 2024 (estimated)
- First posted
- 23 Aug 2023 (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 this interventional clinical trial, researchers will administer electroacupuncture versus sham electroacupuncture to sepsis patients with ARDS and collect objective outcome measures. The study will be divided into 2 groups. The EA group will receive electroacupuncture and the SHAM-EA group will receive sham electroacupuncture. The purpose of this study is to investigate the effect of electroacupuncture on the synthesis of SPMs in sepsis patients with ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture (EA) | Experimental | Device: electroacupuncture treatmentThe acupoints were "Deqi", and the electroacupuncture stimulator was connected and energized. |
| Sham electroacupuncture (SHAM-EA) | Sham comparator | Device: sham electroacupuncture treatmentNo "Deqi" operation was performed on non-acupuncture points, and the electroacupuncture stimulator was connected and not energized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females over the age of 18;
- Diagnosis meets SPESIS 3 criteria for sepsis;
- The diagnosis meets the Berlin diagnostic criteria for ARDS;
- ARDS was diagnosed within 48h;
- Capable of understanding the purpose and risk of the study;
Key exclusion criteria (11 listed)
- ARDS was diagnosed 48h later;
- Pregnancy, lactation or perinatal period;
- malignant tumor;
- Severe liver failure or kidney failure;
- Predicted mortality risk of patients within 24h>80%;
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 |
|---|---|---|
| electroacupuncture treatmentPatients received acupuncture on both sides of the Zusanli (ST36) acupuncture points, and after "Deqi ", the needle was connected to an electro-acupuncture device (Hwato, Suzhou Medical ). The EA stimulation lasted for 30 min. | Device | Electroacupuncture (EA) |
| sham electroacupuncture treatmentThe participants in the SHAM-EA group performed shallow punctures at the bilateral non-acupuncture points, did not perform the "Deqi" operation, and were connected to the electroacupuncture stimulator but not energized. | Device | Sham electroacupuncture (SHAM-EA) |
Primary outcome
Serum levels of Lipoxin A4 (LXA4)
Time frame: Up to 7 days
Serum levels of LXA4 were measured in post-intervention patients and levels were compared to Day 0.
9 secondary outcomes
LXA4 levels in BALF
Time frame: Up to 7 days
Ventilation-free days
Time frame: Up to 28 days
Oxygenation index
Time frame: Up to 7 days
Ventilator-provided positive end-expiratory pressure (PEEP)
Time frame: Up to 7 days
plateau pressure
Time frame: Up to 7 days
tidal volume
Time frame: Up to 7 days
Inflammation biomarkers Inflammation levels
Time frame: Up to 7 days
Sequential Organ-Failure Assessment (SOFA) score
Time frame: Up to 7 days
Rate of electroacupuncture-related adverse events
Time frame: Up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Background: PubMed 34646018Liu S, Wang Z, Su Y, Qi L, Yang W, Fu M, Jing X, Wang Y, Ma Q. A neuroanatomical basis for electroacupuncture to drive the vagal-adrenal axis. Nature. 2021 Oct;598(7882):641-645. doi: 10.1038/s41586-021-04001-4. Epub 2021 Oct 13.
- Background: PubMed 23480440Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
- Background: PubMed 29937192Cecconi M, Evans L, Levy M, Rhodes A. Sepsis and septic shock. Lancet. 2018 Jul 7;392(10141):75-87. doi: 10.1016/S0140-6736(18)30696-2. Epub 2018 Jun 21.
- Background: PubMed 31573637Fowler AA 3rd, Truwit JD, Hite RD, Morris PE, DeWilde C, Priday A, Fisher B, Thacker LR 2nd, Natarajan R, Brophy DF, Sculthorpe R, Nanchal R, Syed A, Sturgill J, Martin GS, Sevransky J, Kashiouris M, Hamman S, Egan KF, Hastings A, Spencer W, Tench S, Mehkri O, Bindas J, Duggal A, Graf J, Zellner S, Yanny L, McPolin C, Hollrith T, Kramer D, Ojielo C, Damm T, Cassity E, Wieliczko A, Halquist M. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019 Oct 1;322(13):1261-1270. doi: 10.1001/jama.2019.11825.
- 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.
Jianbo Yu, MD study director
Tianjin Nankai Hospital
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 treatment in people with Sepsis and Acute Respiratory Distress Syndrome, 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 6 inclusion and 11 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 26 Mar 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. 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 (+8615344422323, 30717008@nankai.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of Lipoxin A4 (LXA4) (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06006325, which also lists 4 linked publications.
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 26 Mar 2024.