Clinical trial NCT06006325: Electroacupuncture Modulates SPMs Metabolism and Respiratory Symptoms in Patients With Sepsis Complicating ARDS
Official title: Electroacupuncture Modulates the Metabolism of SPMs and Ameliorates Respiratory Symptoms and Inflammation in Patients With Sepsis Complicating ARDS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Acute Respiratory Distress Syndrome
Lead sponsor: Tianjin Nankai Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Males or females over the age of 18;
2. Diagnosis meets SPESIS 3 criteria for sepsis;
3. The diagnosis meets the Berlin diagnostic criteria for ARDS;
4. ARDS was diagnosed within 48h;
5. Capable of understanding the purpose and risk of the study;
6. Patients or proxy must give written informed consent before any assessment is performed.

Exclusion Criteria:

1. ARDS was diagnosed 48h later;
2. Pregnancy, lactation or perinatal period;
3. malignant tumor;
4. Severe liver failure or kidney failure;
5. Predicted mortality risk of patients within 24h\>80%;
6. Severe end-stage lung disease;
7. ECMO patients are undergoing implementation;
8. HIV seropositive or Syphilis seropositive;
9. Any clinical-relevant condition that might affect study participation and/or study results;
10. Participation in any other intervention trial;
11. Unwillingness or inability to following the study protocol in the investigators opinion.

Primary outcomes:
measure: Serum levels of Lipoxin A4 (LXA4)
timeFrame: Up to 7 days
Secondary outcomes:
measure: LXA4 levels in BALF
timeFrame: Up to 7 days
measure: Ventilation-free days
timeFrame: Up to 28 days
measure: Oxygenation index
timeFrame: Up to 7 days
measure: Ventilator-provided positive end-expiratory pressure (PEEP)
timeFrame: Up to 7 days
measure: plateau pressure
timeFrame: Up to 7 days
measure: tidal volume
timeFrame: Up to 7 days
measure: Inflammation biomarkers Inflammation levels
timeFrame: Up to 7 days
measure: Sequential Organ-Failure Assessment (SOFA) score
timeFrame: Up to 7 days
measure: Rate of electroacupuncture-related adverse events
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Nankai Hospital
name: Jianbo Yu, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
citation: 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.
citation: 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.