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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture (EA) | Experimental | The acupoints were "Deqi", and the electroacupuncture stimulator was connected and energized. |
|
| Sham electroacupuncture (SHAM-EA) | Sham Comparator | No "Deqi" operation was performed on non-acupuncture points, and the electroacupuncture stimulator was connected and not energized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electroacupuncture treatment | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of Lipoxin A4 (LXA4) | Serum levels of LXA4 were measured in post-intervention patients and levels were compared to Day 0. | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| LXA4 levels in BALF | LXA4 levels were measured in the BALF of patients after the intervention and the levels were compared to day 0. | Up to 7 days |
| Ventilation-free days | The number of days the patient was alive and free of mechanical ventilation (MV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianbo Yu, MD | Contact | +8615344422323 | 30717008@nankai.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianbo Yu, MD | Tianjin Nankai Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Nankai Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34646018 | Background | 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. | |
| 23480440 | Background | Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| sham electroacupuncture treatment | Device | 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. |
|
| 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). | Up to 7 days |
| Ventilator-provided positive end-expiratory pressure (PEEP) | Ventilator parameter | Up to 7 days |
| plateau pressure | Ventilator parameter | Up to 7 days |
| tidal volume | Ventilator parameter | 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) | 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. | Up to 7 days |
| Rate of electroacupuncture-related adverse events | Rate of electroacupuncture-related adverse events | Up to 28 days |
| 29937192 | Background | Cecconi 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. |
| 31573637 | Background | Fowler 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |