Muscle Atrophy in Patients With Severe Sepsis (NCT01717651) | Clinical Trial Compass
TerminatedNot Applicable
Muscle Atrophy in Patients With Severe Sepsis
Stopped: slow accrual made study completion unfeasible
United States25 participantsStarted 2011-12
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years
. Required mechanical ventilation for at least 24 hours
Exclusion criteria
. Ventilator liberation anticipated in the next 24 hours
. Known or suspected acute diagnosis of neuromuscular disease causing diffuse or lower extremity weakness (e.g. CVA, spinal cord injury or lesion, Muscular dystrophy, Myasthenia Gravis, GBS)
. Pre-existing lower extremity weakness caused by prior injury, neuromuscular or joint disease
. Wounds, dressings or injuries of the lower extremities or pelvis that prevent muscle testing or CPM
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quadriceps muscle cross sectional area change from day 0 to 7
. Patient's family, physician, or both not in favor of aggressive treatment of patient that includes life-sustaining treatments or the presence of an advance directive indicating the same a. Rationale: Unlikely to survive to seven day endpoint
. More than seventy-two hours of continuous mechanical ventilation previously during this hospitalization
. Non-English speaking subject or legally authorized representative
. Subject and/or Legally authorized representative unavailable to provide informed consent