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NCT Number: NCT06278675

Multiple Study of Electroaccpuncture in ARDS

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, 210029, China

Location contact

Jun Lu, Doctor

CONTACT

[email protected]

+86 13813865758

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture needles

Device
  • 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.
  • 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.

Primary outcomes

  1. Respiratory mechanics indicators 1

    Time frame: Day 0、day 7

    Oxygenation index(P/F)

  2. Respiratory mechanics indicators 2

    Time frame: Day 0、day 7

    Respiratory rate(RR)

  3. Respiratory mechanics indicators 3

    Time frame: Day 0、day 7

    Driving pressure(DP)

  4. Respiratory mechanics indicators 4

    Time frame: Day 0、day 7

    Positive end expiratory pressure(PEEP)

  5. Respiratory mechanics indicators 5

    Time frame: Day 0、day 7

    Mechanical ventilation days(MV days)

  6. Respiratory mechanics indicators 6

    Time frame: Day 0、day 7

    Mechanical ventilation free days(MV free days)

  7. Respiratory mechanics indicators 7

    Time frame: Day 0、day 7

    Extubation situation

Secondary outcomes

  1. Sedation and analgesia

    Time frame: Day 0、day 7

    RASS score

  2. Sedative drug use

    Time frame: Day 0、day 7

    The dose and duration of sedative medication will be recorded.

  3. Analgesic drug use

    Time frame: Day 0、day 7

    The dose and duration of analgesic medication will be recorded.

  4. Inflammatory factors

    Time frame: 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.

  5. CD4、CD8、CD4/CD8

    Time frame: Day 0、day 7

    Flow cytometry will be used to detect serum CD4, CD8 and CD4/CD8 levels.

  6. Vasoactive drugs applications

    Time frame: Day 0 to day 7

    The duration of vasoactive drug use will be recorded.

  7. CRRT applications

    Time frame: Day 0 to day 7

    The duration of continuous renal replacement therapy will be recorded.

  8. ECMO applications

    Time frame: Day 0 to day 7

    The duration of extracorporeal membrane oxygenation will be recorded.

  9. All-cause mortality to day 28

    Time frame: Up to 28 days

    The prognosis of patients on the 28th days will be counted.

  10. All-cause mortality to day 60

    Time frame: Up to 60 days

    The prognosis of patients on the 60th days will be counted.

  11. ICU-free days

    Time frame: 2 year

    The prognosis of patients ICU length of stay will be counted.

  12. Hospital-free days

    Time frame: 2 year

    The prognosis of patients total length of stay will be counted.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Lu, Doctor

CONTACT

[email protected]

+86 13813865758

Sponsors and collaborators

Lead sponsor

Nanjing University of Traditional Chinese Medicine

Other

Registry information

Official study title

A Multicenter Clinical Study on the Effect of Electroacupuncture on the Mechanical Ventilation Strategy in Patients With Sepsis-related ARDS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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