Muscle Atrophy in Patients With Severe Sepsis
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|ClinicalTrials.gov Identifier: NCT01717651|
Recruitment Status : Terminated (slow accrual made study completion unfeasible)
First Posted : October 30, 2012
Last Update Posted : January 18, 2016
|Condition or disease|
|Severe Sepsis Respiratory Failure|
An optional portion of the study is available to help determine if moving the leg repeatedly with a mechanical device helps prevent muscle loss and weakness. In this optional portion of the study, the subject would have a CPM (continuous passive motion) device attached to one of the subject's legs intermittently over the next three days. Without any effort from the subject , the machine would move the subjects leg back and forth (flexing at the hip and the knee) repeatedly.
This machine is approved by the United States Food and Drug Administration (FDA) to treat patients after they have knee replacement surgery to help preserve the range of motion of the joint while minimizing risk of damage to the joint from more intensive exercise. The use of the device for this study is investigational.
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||Muscle Atrophy in Patients With Severe Sepsis|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
a CPM (continuous passive motion) device attached to one of your legs intermittently over the next three days.
- Quadriceps muscle cross sectional area change from day 0 to 7 [ Time Frame: seven days ]Serial measures of quadriceps muscle by non-invasive ultrasound on Day of enrollment and Day 7 after enrollment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717651
|United States, Ohio|
|The Ohio State University Medical Center - University Hospital|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Naeem A Ali, MD||Ohio State University|