Muscle Atrophy in Patients With Severe Sepsis

NCT01717651 | Terminated

• 1 other identifier: 2011H0290
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Severe Sepsis; Respiratory Failure

Keywords

Atrophy; Muscle wasting; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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

  seven days

Study Arms (1)

CPM device

a CPM (continuous passive motion) device attached to one of your legs intermittently over the next three days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age ≥ 18 years
• Required mechanical ventilation for at least 24 hours

You may not qualify if:

• Ventilator liberation anticipated in the next 24 hours
• a. 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)
• a. 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
• a. 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
• a. 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
• a. Rationale: Atrophy mechanisms already active and may degrade ability to detect early changes.
• 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.
• Subject and/or Legally authorized representative unavailable to provide informed consent
• Subject is a Prisoner

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Medical Center - University Hospital

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Sepsis; Respiratory Insufficiency; Atrophy; Muscular Atrophy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathological Conditions, Anatomical; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Naeem A Ali, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Medical Intensive Care Unit (MICU);

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 30, 2012
• Study Start: December 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

US (1)