Acute Respiratory Distress Syndrome, Sepsis
Conditions
Brief summary
In order to clarify the clinical efficacy of electroacupuncture on inhibiting systemic inflammatory response, improving respiratory mechanics parameters and prognosis in patients with sepsis-related ARDS.
Interventions
DEVICEAcupuncture needles
1. Experimental group: Sterile stainless steel needle electroacupuncture treatment was applied, and the acupuncture points were as follows: bilateral Zusanli (ST36), Neiguan (PC6), Hegu (LI4), Shaoshang (LU11), and Feng Long (ST40). 1 time a day, 30 minutes each time, for 7 days. 2. Control group: Placebo needles were applied, and the acupuncture points were as follows: bilateral Zusanli (ST36), Neiguan (PC6), Hegu (LI4), Shaoshang (LU11), and Feng Long (ST40). 1 time a day, 30 minutes each time, for 7 days.
Sponsors
Nanjing University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet the diagnostic criteria of the Surviving Sepsis Campaign: Updated International Guidelines for the Treatment of Sepsis and Septic Shock 2021 * Meet the diagnostic criteria of the European Society of Critical Care Medicine (ESICM) Guidelines for Acute Respiratory Distress Syndrome: Definition, Phenotype and Respiratory Support Strategies * Age \>18 years * Expected duration of mechanical ventilation\>48 hours * Expected ICU stay of more than 7 days * Signed informed consent.
Exclusion criteria
* Participated in other clinical trials * Pregnant, lactating or miscarriage * Patients with disseminated tumors or tumors receiving chemotherapy and other special treatments * Alcohol abuse * Severe cardiovascular, brain, liver, kidney, psychiatric diseases, diabetes, multiple system atrophy, cauda equina injury or myelopathy * Systolic blood pressure \< 90mmHg within 2 hours before the start of the study * Severe burns or severe skin diseases * Pacemaker placement, metal allergy or severe needle sickness * Abnormal coagulation function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory mechanics indicators 2 | Day 0、day 7 | Respiratory rate(RR) |
| Respiratory mechanics indicators 1 | Day 0、day 7 | Oxygenation index(P/F) |
| Respiratory mechanics indicators 3 | Day 0、day 7 | Driving pressure(DP) |
| Respiratory mechanics indicators 4 | Day 0、day 7 | Positive end expiratory pressure(PEEP) |
| Respiratory mechanics indicators 5 | Day 0、day 7 | Mechanical ventilation days(MV days) |
| Respiratory mechanics indicators 6 | Day 0、day 7 | Mechanical ventilation free days(MV free days) |
| Respiratory mechanics indicators 7 | Day 0、day 7 | Extubation situation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ECMO applications | Day 0 to day 7 | The duration of extracorporeal membrane oxygenation will be recorded. |
| All-cause mortality to day 28 | Up to 28 days | The prognosis of patients on the 28th days will be counted. |
| Sedation and analgesia | Day 0、day 7 | RASS score |
| ICU-free days | 2 year | The prognosis of patients ICU length of stay will be counted. |
| Hospital-free days | 2 year | The prognosis of patients total length of stay will be counted. |
| All-cause mortality to day 60 | Up to 60 days | The prognosis of patients on the 60th days will be counted. |
| Sedative drug use | Day 0、day 7 | The dose and duration of sedative medication will be recorded. |
| Analgesic drug use | Day 0、day 7 | The dose and duration of analgesic medication will be recorded. |
| Inflammatory factors | Day 0、day 7 | IL-1β、IL-6、IL-2、IL-4、IL-5、IL-8、IL-10、IL-17、IL-12、 IFN-γ、IFN-α、TNF-α. |
| CD4、CD8、CD4/CD8 | Day 0、day 7 | Flow cytometry will be used to detect serum CD4, CD8 and CD4/CD8 levels. |
| Vasoactive drugs applications | Day 0 to day 7 | The duration of vasoactive drug use will be recorded. |
| CRRT applications | Day 0 to day 7 | The duration of continuous renal replacement therapy will be recorded. |
Countries
China
Contacts
Primary ContactJun Lu, Doctor
Outcome results
None listed