Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients

Sepsis Clinical Trial

— EA-ICUAW  

Official title:

Phase 1 Study of Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients With Sepsis/Multiple Organ Dysfunction Syndrome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02204215
• Other study ID #: EA-ICUAW
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 25, 2014
• Last updated: July 28, 2014
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2014
• Source: Jiangsu Province Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine
• Study type: Interventional

Clinical Trial Summary

Intensive care unit acquired weakness (ICU-AW) is common and dramatically affect recovery. The purpose of this study is to determine whether electric acupuncture therapy is effective in the treatment of ICU-AW especially in the patients receiving mechanical ventilation with sepsis or multiorgan system failure.

Description:

The principle of acupuncture is to produce bioelectric current, as a consequence, to invigorate the circulation, promote tissue regeneration, relieve pain, enhance the immune function, etc. And electric acupuncture can stimulate bioelectricity activities at acupoints, out of reach for ordinary acupuncture effect, especially in the fields of nerve/muscle recovery and regeneration.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of sepsis or multiple organ dysfunction syndrome

• Within 48 hours from the initiation of mechanical ventilation

Exclusion Criteria:

• Pregnant patients

• Neuromuscular disease or cerebrovascular accident

• With temporary or permanent pacemaker

• Need to use neuromuscular blocking agents

• Inactivity for more than 5 days before ICU admission

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Organ Dysfunction Syndrome
• Multiple Organ Failure
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis

Intervention

Device:
• electric acupuncture
Electric acupuncture therapy was made on LI4, LI11, ST36, and ST41 on four limbs for each patient, 30 min for each time, twice per day. Starting from the beginning of mechanical ventilation, to the weaning of the mechanical ventilation.

Other:
• conservative
General treatment, without electric acupuncture, include passive range-of-motion exercise,q2H turning,minimizing the use of sedation, etc.

Locations

Country	Name	City	State
China	Department of Intensive Care Unit, Jiangsu Province Hospital of TCM	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Province Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	strength related parameters	muscle force, arm circumference, skin fold thickness	Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks	No
Secondary	mechanical ventilation duration	the time span from the beginning of mechanical ventilation, till the weaning of mechanical ventilation	Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks	No
Secondary	28-day mortality	the mortality till the 28th day after mechanical ventilation	Participants will be followed until the 28th day after mechanical ventilation	No
Secondary	number of participants with adverse events of electric acupuncture	the adverse enents include fainting, infection, bleeding, viscera damage, and so on.	Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks	Yes
Secondary	ICU duration	the time span from the beginning of mechanical ventilation, till the date of discharge from the ICU	Participants will be followed until the date of discharge from the ICU, an expected average of 8 weeks	No