Acute Respiratory Distress Syndrome, Sepsis
Conditions
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.
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.
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.
Sponsors
Tianjin Nankai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| tidal volume | Up to 7 days | Ventilator parameter |
Countries
China
Contacts
Primary ContactJianbo Yu, MD
Outcome results
None listed