Clinical trial NCT06278675: Multiple Study of Electroaccpuncture in ARDS
Official title: A Multicenter Clinical Study on the Effect of Electroacupuncture on the Mechanical Ventilation Strategy in Patients With Sepsis-related ARDS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Sepsis
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Respiratory mechanics indicators 1
timeFrame: Day 0、day 7
measure: Respiratory mechanics indicators 2
timeFrame: Day 0、day 7
measure: Respiratory mechanics indicators 3
timeFrame: Day 0、day 7
measure: Respiratory mechanics indicators 4
timeFrame: Day 0、day 7
measure: Respiratory mechanics indicators 5
timeFrame: Day 0、day 7
measure: Respiratory mechanics indicators 6
timeFrame: Day 0、day 7
measure: Respiratory mechanics indicators 7
timeFrame: Day 0、day 7
Secondary outcomes:
measure: Sedation and analgesia
timeFrame: Day 0、day 7
measure: Sedative drug use
timeFrame: Day 0、day 7
measure: Analgesic drug use
timeFrame: Day 0、day 7
measure: Inflammatory factors
timeFrame: Day 0、day 7
measure: CD4、CD8、CD4/CD8
timeFrame: Day 0、day 7
measure: Vasoactive drugs applications
timeFrame: Day 0 to day 7
measure: CRRT applications
timeFrame: Day 0 to day 7
measure: ECMO applications
timeFrame: Day 0 to day 7
measure: All-cause mortality to day 28
timeFrame: Up to 28 days
measure: All-cause mortality to day 60
timeFrame: Up to 60 days
measure: ICU-free days
timeFrame: 2 year
measure: Hospital-free days
timeFrame: 2 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine
state: Jiangsu
Study officials:
affiliation: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Jun Lu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: