NCT02204215

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 30, 2014

Status Verified

July 1, 2014

Enrollment Period

1.9 years

First QC Date

July 25, 2014

Last Update Submit

July 28, 2014

Conditions

Respiratory FailureSepsisMultiple Organ Dysfunction Syndrome

Keywords

WeaknessMechanical VentilationAcupuncture Therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • mechanical ventilation duration

    Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks

  • 28-day mortality

    Participants will be followed until the 28th day after mechanical ventilation

  • number of participants with adverse events of electric acupuncture

    Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks

  • ICU duration

    Participants will be followed until the date of discharge from the ICU, an expected average of 8 weeks

Study Arms (1)

electric acupuncture & conservative

EXPERIMENTAL

Electric acupuncture therapy on four limbs 30 min each time, twice per day; or conservative treatment without electric acupuncture.

Device: electric acupunctureOther: conservative

Interventions

electric acupunctureDEVICE

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.

electric acupuncture & conservative
conservativeOTHER

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

electric acupuncture & conservative

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of sepsis or multiple organ dysfunction syndrome
  • Within 48 hours from the initiation of mechanical ventilation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Intensive Care Unit, Jiangsu Province Hospital of TCM

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Respiratory InsufficiencySepsisMultiple Organ FailureAsthenia

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockSigns and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Xing Wang, M.D.

    Director of Intensive Care Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Intensive Care Unit

Study Record Dates

First Submitted

July 25, 2014

First Posted

July 30, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 30, 2014

Record last verified: 2014-07

Locations

CN(1)