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

Not Applicable

Recruiting

• Conditions: Sepsis; Acute Respiratory Distress Syndrome
• Interventions: Device: electroacupuncture treatment; Device: sham electroacupuncture treatment

• Registration Number: NCT06006325
• Lead Sponsor: Tianjin Nankai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-16
• Study Start: 2023-08-20
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-26
• Primary Completion: 2024-07-30
• Study Completion: 2024-10-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture (EA)	electroacupuncture treatment	The acupoints were "Deqi", and the electroacupuncture stimulator was connected and energized.
Sham electroacupuncture (SHAM-EA)	sham electroacupuncture treatment	No "Deqi" operation was performed on non-acupuncture points, and the electroacupuncture stimulator was connected and not energized.

Primary Outcome Measures

Name	Time	Method
Serum levels of Lipoxin A4 (LXA4)	Up to 7 days	Serum levels of LXA4 were measured in post-intervention patients and levels were compared to Day 0.

Secondary Outcome Measures

Name	Time	Method
Oxygenation index	Up to 7 days	The ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).
plateau pressure	Up to 7 days	Ventilator parameter
Sequential Organ-Failure Assessment (SOFA) score	Up to 7 days	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.
LXA4 levels in BALF	Up to 7 days	LXA4 levels were measured in the BALF of patients after the intervention and the levels were compared to day 0.
Ventilation-free days	Up to 28 days	The number of days the patient was alive and free of mechanical ventilation (MV)
Inflammation biomarkers Inflammation levels	Up to 7 days	Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6)
Ventilator-provided positive end-expiratory pressure (PEEP)	Up to 7 days	Ventilator parameter
tidal volume	Up to 7 days	Ventilator parameter
Rate of electroacupuncture-related adverse events	Up to 28 days	Rate of electroacupuncture-related adverse events

Trial Locations

Locations (1)

Tianjin Nankai Hospital; 🇨🇳 Tianjin, Tianjin, China