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

Tianjin Nankai Hospital

Status: Enrolling

Conditions: Acute Respiratory Distress Syndrome; Sepsis

Treatments: Device: electroacupuncture treatment; Device: sham electroacupuncture treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06006325

NKYY_YXKT_IRB_2022_023_01

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Electroacupuncture (EA)

Experimental group

Description:

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

Treatment:

Device: electroacupuncture treatment

Sham electroacupuncture (SHAM-EA)

Sham Comparator group

Description:

No "Deqi" operation was performed on non-acupuncture points, and the electroacupuncture stimulator was connected and not energized.

Treatment:

Device: sham electroacupuncture treatment