Multiple Study of Electroaccpuncture in ARDS

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06278675
• Other study ID #: SEOVA
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 10, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Nanjing University of Traditional Chinese Medicine
• Contact: Jun Lu, Doctor
• Phone: +86 13813865758
• Email: lujun[@]njucm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 264
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Sepsis

Intervention

Device:
• Acupuncture needles
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.

Locations

Country	Name	City	State
China	Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory mechanics indicators 1	Oxygenation index(P/F)	Day 0?day 7
Primary	Respiratory mechanics indicators 2	Respiratory rate(RR)	Day 0?day 7
Primary	Respiratory mechanics indicators 3	Driving pressure(DP)	Day 0?day 7
Primary	Respiratory mechanics indicators 4	Positive end expiratory pressure(PEEP)	Day 0?day 7
Primary	Respiratory mechanics indicators 5	Mechanical ventilation days(MV days)	Day 0?day 7
Primary	Respiratory mechanics indicators 6	Mechanical ventilation free days(MV free days)	Day 0?day 7
Primary	Respiratory mechanics indicators 7	Extubation situation	Day 0?day 7
Secondary	Sedation and analgesia	RASS score	Day 0?day 7
Secondary	Sedative drug use	The dose and duration of sedative medication will be recorded.	Day 0?day 7
Secondary	Analgesic drug use	The dose and duration of analgesic medication will be recorded.	Day 0?day 7
Secondary	Inflammatory factors	IL-1ß?IL-6?IL-2?IL-4?IL-5?IL-8?IL-10?IL-17?IL-12? IFN-??IFN-a?TNF-a.	Day 0?day 7
Secondary	CD4?CD8?CD4/CD8	Flow cytometry will be used to detect serum CD4, CD8 and CD4/CD8 levels.	Day 0?day 7
Secondary	Vasoactive drugs applications	The duration of vasoactive drug use will be recorded.	Day 0 to day 7
Secondary	CRRT applications	The duration of continuous renal replacement therapy will be recorded.	Day 0 to day 7
Secondary	ECMO applications	The duration of extracorporeal membrane oxygenation will be recorded.	Day 0 to day 7
Secondary	All-cause mortality to day 28	The prognosis of patients on the 28th days will be counted.	Up to 28 days
Secondary	All-cause mortality to day 60	The prognosis of patients on the 60th days will be counted.	Up to 60 days
Secondary	ICU-free days	The prognosis of patients ICU length of stay will be counted.	2 year
Secondary	Hospital-free days	The prognosis of patients total length of stay will be counted.	2 year