Severe SepsisNCT01717651
Muscle Atrophy in Patients With Severe Sepsis
An observational study of Severe Sepsis and Respiratory Failure, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Respiratory Failure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A) Inclusion Criteria 1. Age ≥ 18 years 2. Required mechanical ventilation for at least 24 hours
- Inclusion Criteria
- Age ≥ 18 years
- Required mechanical ventilation for at least 24 hours
- Exclusion Criteria
- Ventilator liberation anticipated in the next 24 hours
- Rationale: short duration of illness anticipated, preventing achievement of primary endpoint
- 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)
- Rationale: chronic lower extremity weakness will impact anticipated physical recovery and relevance of atrophy observations
- Pre-existing lower extremity weakness caused by prior injury, neuromuscular or joint disease
- Rationale: Inability to participate in usual care therapy and CPM. Impacts functional recovery
- Wounds, dressings or injuries of the lower extremities or pelvis that prevent muscle testing or CPM
- Rationale: Inability to participate in US, exam or CPM
- 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
- Rationale: Atrophy mechanisms already active and may degrade ability to detect early changes.
- Non-English speaking subject or legally authorized representative
- Rationale: This study does not have the funding necessary to translate consents and inability to ensure cooperation with testing.
- Subject and/or Legally authorized representative unavailable to provide informed consent
- Subject is a Prisoner
- Pregnancy (excluded from CPM portion only) a. Rationale: Pregnant patients can develop the supine hypotensive syndrome (where the uterus compromises venous return due to compression of the IVC). This typically occurs only after 20 weeks gestation. To assure safety, any patient who self identifies as pregnant or has a positive urine pregnancy test on admission will not be offered CPM since it requires extended periods in the supine position.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center - University Hospital
Columbus, Ohio, 43210
About this study
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
Read the 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.
- Conditions
- Severe Sepsis, Respiratory Failure
- Keywords
- Atrophy, Muscle wasting, Sepsis
- Medical subject headings
- Sepsis, Respiratory Insufficiency, Atrophy, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CPM device | a CPM (continuous passive motion) device attached to one of your legs intermittently over the next three days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps muscle cross sectional area change from day 0 to 7
Serial measures of quadriceps muscle by non-invasive ultrasound on Day of enrollment and Day 7 after enrollment
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startDec 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: slow accrual made study completion unfeasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naeem Ali, MD, Ohio State University
- Investigators
- Naeem A Ali, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717651
- Sponsor's protocol ID
- 2011H0290
- Status last verified
- Jan 2016
- First submitted
- 4 Oct 2012
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Atrophy in Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT01717651
- Acronym / sponsor ID
- 2011H0290
- Conditions
- Severe Sepsis, Respiratory Failure
- Keywords
- Atrophy, Muscle wasting, Sepsis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow accrual made study completion unfeasible
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPM device | – | –a CPM (continuous passive motion) device attached to one of your legs intermittently over the next three days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A) Inclusion Criteria 1. Age ≥ 18 years 2. Required mechanical ventilation for at least 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: slow accrual made study completion unfeasible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naeem A Ali, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Respiratory Failure, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow accrual made study completion unfeasible). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps muscle cross sectional area change from day 0 to 7 (time frame: seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.