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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2024-10-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Sepsis Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Electroacupuncture (EA)

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

Group Type EXPERIMENTAL

electroacupuncture treatment

Intervention Type 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.

Sham electroacupuncture (SHAM-EA)

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

Group Type SHAM_COMPARATOR

sham electroacupuncture treatment

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No