Trial Outcomes & Findings for Effect of Different Electric Muscle Stimulation in Patients With Severe Sepsis and Respiratory Failure (NCT NCT01895647)
NCT ID: NCT01895647
Last Updated: 2019-07-08
Results Overview
Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)
TERMINATED
NA
25 participants
21 days
2019-07-08
Participant Flow
Participant milestones
| Measure |
Biceps Stimulation
EMS
EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
|
Quadriceps Stimulation
EMS
EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
|
Control
Control group without electric muscle stimulation
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
7
|
|
Overall Study
COMPLETED
|
8
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Biceps Stimulation
n=8 Participants
EMS
EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
|
Quadriceps Stimulation
n=10 Participants
EMS
EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
|
Control
n=7 Participants
Control group without electric muscle stimulation
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
78 years
n=8 Participants
|
78 years
n=10 Participants
|
77.5 years
n=7 Participants
|
78 years
n=25 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=8 Participants
|
8 Participants
n=10 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=25 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
8 participants
n=8 Participants
|
10 participants
n=10 Participants
|
7 participants
n=7 Participants
|
25 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 21 daysPatient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)
Outcome measures
| Measure |
Biceps Stimulation
n=8 Participants
EMS
EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
|
Quadriceps Stimulation
n=10 Participants
EMS
EMS: Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
|
Control
n=7 Participants
Control group without electric muscle stimulation
|
|---|---|---|---|
|
Ventilator-dependant Days
|
6 days
Interval 5.5 to 7.0
|
7 days
Interval 5.0 to 11.0
|
6 days
Interval 6.0 to 15.0
|
SECONDARY outcome
Timeframe: 21 daysPopulation: The measurement cannot be collected because of the patients' drowsiness or incorporation.
muscle power measurement by hand grip digital dynamometer every 2 days
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: First 1 week.Population: The data was not completed because undetected IL-15 in first two samples. No data collection was performed for further samples.
Serum interleukin(IL)-1B, IL-6, IL-8, IL-10, IL-15 and tumor necrosis factor(TNF)-alpha will be measured before/after first section of EMS, and after fifth EMS section.
Outcome measures
Outcome data not reported
Adverse Events
Biceps Stimulation
Quadriceps Stimulation
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place