Muscle Atrophy in Patients With Severe Sepsis

Terminated

• Conditions: Respiratory Failure; Severe Sepsis

• Registration Number: NCT01717651
• Lead Sponsor: Ohio State University

Brief Summary

This study is being done to help determine whether patients with severe sepsis (overwhelming inflammation in the body as a result of an infection) lose muscle and become weak more rapidly than patients with other severe illnesses. Weakness and muscle loss that develops after a severe illness is a serious problem. Patients who develop weakness and have a decrease in muscle size often have to stay in the hospital longer and have a higher chance of dying. At the current time, it is not clear whether certain severe illnesses are more likely to cause weakness and muscle loss. This study will be done to measure the changes in muscle size and strength as a result of each patient's illness

Detailed Description

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quadriceps muscle cross sectional area change from day 0 to 7	seven days	Serial measures of quadriceps muscle by non-invasive ultrasound on Day of enrollment and Day 7 after enrollment

Trial Locations

Locations (1)

The Ohio State University Medical Center - University Hospital; 🇺🇸 Columbus, Ohio, United States