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Muscle Atrophy in Patients With Severe Sepsis

This study has been terminated.
(slow accrual made study completion unfeasible)
Sponsor:
Information provided by (Responsible Party):
Naeem Ali, MD, Ohio State University
ClinicalTrials.gov Identifier:
NCT01717651
First received: October 4, 2012
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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


Condition
Severe Sepsis
Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Muscle Atrophy in Patients With Severe Sepsis

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Quadriceps muscle cross sectional area change from day 0 to 7 [ Time Frame: seven days ] [ Designated as safety issue: No ]
    Serial measures of quadriceps muscle by non-invasive ultrasound on Day of enrollment and Day 7 after enrollment


Enrollment: 25
Study Start Date: December 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
CPM device
a CPM (continuous passive motion) device attached to one of your legs intermittently over the next three days.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

A) Inclusion Criteria

  1. Age ≥ 18 years
  2. Required mechanical ventilation for at least 24 hours
Criteria

A) Inclusion Criteria

  1. Age ≥ 18 years
  2. Required mechanical ventilation for at least 24 hours

B) Exclusion Criteria

  1. Ventilator liberation anticipated in the next 24 hours

    a. Rationale: short duration of illness anticipated, preventing achievement of primary endpoint

  2. 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)

    a. Rationale: chronic lower extremity weakness will impact anticipated physical recovery and relevance of atrophy observations

  3. Pre-existing lower extremity weakness caused by prior injury, neuromuscular or joint disease

    a. Rationale: Inability to participate in usual care therapy and CPM. Impacts functional recovery

  4. Wounds, dressings or injuries of the lower extremities or pelvis that prevent muscle testing or CPM

    a. Rationale: Inability to participate in US, exam or CPM

  5. 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
  6. More than seventy-two hours of continuous mechanical ventilation previously during this hospitalization

    a. Rationale: Atrophy mechanisms already active and may degrade ability to detect early changes.

  7. Non-English speaking subject or legally authorized representative

    a. Rationale: This study does not have the funding necessary to translate consents and inability to ensure cooperation with testing.

  8. Subject and/or Legally authorized representative unavailable to provide informed consent
  9. Subject is a Prisoner
  10. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717651

Locations
United States, Ohio
The Ohio State University Medical Center - University Hospital
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Naeem A Ali, MD Ohio State University
  More Information

No publications provided

Responsible Party: Naeem Ali, MD, Medical Director, Medical Intensive Care Unit (MICU);, Ohio State University
ClinicalTrials.gov Identifier: NCT01717651     History of Changes
Other Study ID Numbers: 2011H0290
Study First Received: October 4, 2012
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Atrophy
Muscle wasting
Sepsis

Additional relevant MeSH terms:
Atrophy
Muscular Atrophy
Respiratory Insufficiency
Sepsis
Toxemia
Infection
Inflammation
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathologic Processes
Pathological Conditions, Anatomical
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 27, 2014