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

Tianjin Nankai Hospital70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sepsis Acute Respiratory Distress Syndrome

Interventions

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 treatmentDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Serum levels of Lipoxin A4 (LXA4)

Serum levels of LXA4 were measured in post-intervention patients and levels were compared to Day 0.

Time frame: Up to 7 days

Secondary Outcomes

LXA4 levels in BALF

LXA4 levels were measured in the BALF of patients after the intervention and the levels were compared to day 0.

Time frame: Up to 7 days

Ventilation-free days

The number of days the patient was alive and free of mechanical ventilation (MV)

Time frame: Up to 28 days

Oxygenation index

The ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).

Time frame: Up to 7 days

Ventilator-provided positive end-expiratory pressure (PEEP)

Ventilator parameter

Time frame: Up to 7 days

plateau pressure

Ventilator parameter

Time frame: Up to 7 days

tidal volume

Ventilator parameter

Time frame: Up to 7 days

Inflammation biomarkers Inflammation levels

Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6)

Time frame: Up to 7 days

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.

Time frame: Up to 7 days

Rate of electroacupuncture-related adverse events

Time frame: Up to 28 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts