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Clinical Trials/NCT01717651
NCT01717651
Terminated
Not Applicable

Muscle Atrophy in Patients With Severe Sepsis

Ohio State University1 site in 1 country25 target enrollmentDecember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Sepsis
Sponsor
Ohio State University
Enrollment
25
Locations
1
Primary Endpoint
Quadriceps muscle cross sectional area change from day 0 to 7
Status
Terminated
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
February 2013
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Naeem Ali, MD

Medical Director, Medical Intensive Care Unit (MICU);

Ohio State University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (1)

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