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

Sponsor

Tianjin Nankai Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06006325

Collaborator

(none)

Enrollment

Location

Arms

6.4

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Acute Respiratory Distress Syndrome	Device: electroacupuncture treatment Device: sham electroacupuncture treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 20, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 2, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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)
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).
Ventilator-provided positive end-expiratory pressure (PEEP) [Up to 7 days]
Ventilator parameter
plateau pressure [Up to 7 days]
Ventilator parameter
tidal volume [Up to 7 days]
Ventilator parameter
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)
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.
Rate of electroacupuncture-related adverse events [Up to 28 days]
Rate of electroacupuncture-related adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males or females over the age of 18;
Diagnosis meets SPESIS 3 criteria for sepsis;
The diagnosis meets the Berlin diagnostic criteria for ARDS;
ARDS was diagnosed within 48h;
Capable of understanding the purpose and risk of the study;
Patients or proxy must give written informed consent before any assessment is performed.

Exclusion Criteria:

ARDS was diagnosed 48h later;
Pregnancy, lactation or perinatal period;
malignant tumor;
Severe liver failure or kidney failure;
Predicted mortality risk of patients within 24h>80%;
Severe end-stage lung disease;
ECMO patients are undergoing implementation;
HIV seropositive or Syphilis seropositive;
Any clinical-relevant condition that might affect study participation and/or study results;
Participation in any other intervention trial;
Unwillingness or inability to following the study protocol in the investigators opinion.