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

Sepsis Clinical Trial

Official title:

Electroacupuncture Modulates the Metabolism of SPMs and Ameliorates Respiratory Symptoms and Inflammation in Patients With Sepsis Complicating ARDS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06006325
• Other study ID #: NKYY_YXKT_IRB_2022_023_01
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2023
• Est. completion date: October 2, 2024

Study information

• Verified date: March 2024
• Source: Tianjin Nankai Hospital
• Contact: Jianbo Yu, MD
• Phone: +8615344422323
• Email: 30717008[@]nankai.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Sepsis
• Signs and Symptoms, Respiratory
• Toxemia

Intervention

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 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.

Locations

Country	Name	City	State
China	Tianjin Nankai Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Ventilation-free days	The number of days the patient was alive and free of mechanical ventilation (MV)	Up to 28 days
Secondary	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
Secondary	Ventilator-provided positive end-expiratory pressure (PEEP)	Ventilator parameter	Up to 7 days
Secondary	plateau pressure	Ventilator parameter	Up to 7 days
Secondary	tidal volume	Ventilator parameter	Up to 7 days
Secondary	Inflammation biomarkers Inflammation levels	Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1ß), and interleukin-6 (IL-6)	Up to 7 days
Secondary	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
Secondary	Rate of electroacupuncture-related adverse events	Rate of electroacupuncture-related adverse events	Up to 28 days