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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: electroacupuncture treatment; Device: sham electroacupuncture treatment

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianbo Yu, MD; Phone Number: +8615344422323; Email: 30717008@nankai.edu.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Recruiting
      • Tianjin Nankai Hospital
      • Contact: Shuan Dong, Professor; Phone Number: （022）27435027 （022）27435008; Email: dongshuan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture (EA); The acupoints were "Deqi", and the electroacupuncture stimulator was connected and energized.	Device: electroacupuncture treatment; 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 Comparator: Sham electroacupuncture (SHAM-EA); No "Deqi" operation was performed on non-acupuncture points, and the electroacupuncture stimulator was connected and not energized.	Device: sham electroacupuncture treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Tianjin Nankai Hospital
• Investigators: Study Director: Jianbo Yu, MD, Tianjin Nankai Hospital

Publications and helpful links

General Publications

• Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
• 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. Erratum In: JAMA. 2020 Jan 28;323(4):379.
• 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. Erratum In: Nature. 2022 Jan;601(7893):E9.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): October 2, 2024

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Sepsis; Toxemia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Signs and Symptoms, Respiratory
• Other Study ID Numbers: NKYY_YXKT_IRB_2022_023_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No