Electroacupuncture Modulates SPMs Metabolism and Respiratory Symptoms in Patients With Sepsis Complicating ARDS

NCT06006325 | Recruiting

• 1 other identifier: NKYY_YXKT_IRB_2022_023_01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• LXA4 levels in BALF

  Up to 7 days

• Ventilation-free days

  Up to 28 days

• Oxygenation index

  Up to 7 days

• Ventilator-provided positive end-expiratory pressure (PEEP)

  Up to 7 days

• plateau pressure

  Up to 7 days

Study Arms (2)

Electroacupuncture (EA)

EXPERIMENTAL

The acupoints were "Deqi", and the electroacupuncture stimulator was connected and energized.

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.

Device: sham electroacupuncture treatment

Interventions

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.

Electroacupuncture (EA)

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.

Sham electroacupuncture (SHAM-EA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Tianjin Nankai Hospital: lead

Study Sites (1)

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 34646018 BACKGROUND

• Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.

  PMID: 23480440 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.

  PMID: 29937192 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.

  PMID: 31573637 BACKGROUND

MeSH Terms

Conditions

Sepsis; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jianbo Yu, MD

  Tianjin Nankai Hospital

  STUDY DIRECTOR

Central Study Contacts

Jianbo Yu, MD

CONTACT

+8615344422323; 30717008@nankai.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 23, 2023
• Study Start: August 20, 2023
• Primary Completion: July 30, 2024
• Study Completion: October 2, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)