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Not yet recruitingNCT06278675Updated Apr 23, 2024

Multiple Study of Electroaccpuncture in ARDS

An interventional study of Acupuncture needles in Acute Respiratory Distress Syndrome and Sepsis, sponsored by Nanjing University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by Nanjing University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
264
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Respiratory Distress Syndrome
  • Sepsis
03

In context

Respiratory Distress Syndrome

1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.

This study's planned enrollment of 264 is above the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Nanjing University of Traditional Chinese Medicine is the lead sponsor of 17 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
264 participants (estimated)

Study arms

  • Experimental
    Experimental group

    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.

    Device: Acupuncture needles

  • No intervention
    Control group

    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.

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.

06

What researchers measure

Primary outcomes

  1. Respiratory mechanics indicators 1

    Oxygenation index(P/F)

    Time frame: Day 0、day 7

  2. Respiratory mechanics indicators 2

    Respiratory rate(RR)

    Time frame: Day 0、day 7

  3. Respiratory mechanics indicators 3

    Driving pressure(DP)

    Time frame: Day 0、day 7

  4. Respiratory mechanics indicators 4

    Positive end expiratory pressure(PEEP)

    Time frame: Day 0、day 7

  5. Respiratory mechanics indicators 5

    Mechanical ventilation days(MV days)

    Time frame: Day 0、day 7

  6. Respiratory mechanics indicators 6

    Mechanical ventilation free days(MV free days)

    Time frame: Day 0、day 7

  7. Respiratory mechanics indicators 7

    Extubation situation

    Time frame: Day 0、day 7

Secondary outcomes

  1. Sedation and analgesia

    RASS score

    Time frame: Day 0、day 7

  2. Sedative drug use

    The dose and duration of sedative medication will be recorded.

    Time frame: Day 0、day 7

  3. Analgesic drug use

    The dose and duration of analgesic medication will be recorded.

    Time frame: Day 0、day 7

  4. Inflammatory factors

    IL-1β、IL-6、IL-2、IL-4、IL-5、IL-8、IL-10、IL-17、IL-12、 IFN-γ、IFN-α、TNF-α.

    Time frame: Day 0、day 7

  5. CD4、CD8、CD4/CD8

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

    Time frame: Day 0、day 7

  6. Vasoactive drugs applications

    The duration of vasoactive drug use will be recorded.

    Time frame: Day 0 to day 7

  7. CRRT applications

    The duration of continuous renal replacement therapy will be recorded.

    Time frame: Day 0 to day 7

  8. ECMO applications

    The duration of extracorporeal membrane oxygenation will be recorded.

    Time frame: Day 0 to day 7

  9. All-cause mortality to day 28

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

    Time frame: Up to 28 days

  10. All-cause mortality to day 60

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

    Time frame: Up to 60 days

  11. ICU-free days

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

    Time frame: 2 year

  12. Hospital-free days

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

    Time frame: 2 year

07

Study locations

1 site
  • Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine
    Nanjing, Jiangsu 210029, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06278675
Lead sponsor
Nanjing University of Traditional Chinese Medicine
Responsible party
Jun Lu, MD (Director, Nanjing University of Traditional Chinese Medicine) — Principal investigator
First posted
Feb 26, 2024
Start date
May 10, 2024 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 23, 2024

Study contacts

Jun Lu, Doctor
Contact
lujun@njucm.edu.cn
+86 13813865758
Jun Lu, Doctor
principal investigator · Jiangsu Province Hospital of Chinese Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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