An interventional study of Muscle stimulation with Niveus medical stimulator and measurement of maximal isometric twitch strength in Sepsis, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-19.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
The purpose of this research study is to see if electrical stimulation of the leg muscles will improve strength in patients receiving mechanical ventilation in the intensive care unit (ICU). ICU care frequently results in chronically critically ill (CCI) patients. Some CCI patients develop persistent inflammation/immunosuppression and catabolism syndrome (PICS), and they have morbid long-term outcomes. CCI patients with PICS often develop severe limb muscle atrophy, weakness and accelerated protein catabolism. Limb muscle dysfunction in PICS is due to many factors including sepsis/inflammation, proteolysis, apoptosis, and inactivity. Despite the seriousness of limb muscle weakness in CCI patients receiving mechanical ventilation, little is known about exercise strategies to treat this problem. There is limited knowledge about how strength training impacts inflammation and catabolism in CCI patients. In addition, an assessment of the effect of exercise on markers of inflammation and protein catabolism on muscle samples obtained with biopsy techniques and venous blood samples will be performed. This project will further understanding of how treating CCI-related muscle weakness with strength training cannot only improve muscle function, but also potentially blunt the inflammation and catabolism of PICS.
As a participant in the study, the following will take place: Assignment to study groups: a random assignment will be done to one of two groups by a list generated by a computer program, much like flipping a coin. One group of subjects will be assigned to an effective muscle stimulation group and the second group will be assigned to a group that will receive ineffective stimulation (Control or Sham). Muscle stimulation will be performed with a Niveus medical stimulator on both quadriceps muscle groups for 30 minutes, five days per week. The stimulator will be individually adjusted in terms of intensity of stimulation to elicit a visible or palpable quadriceps muscle contraction. Four contractions per minute will be performed for a total of approximately 120 contractions per 30 minute treatment. Isometric Muscle strength testing: All subjects will undergo isometric muscle strength testing. Maximal isometric twitch strength will be measured by placing the subjects' dominant leg in a frame that will hold the knee at 60°. A cuff will be placed around the patient's ankle and will be connected to an electronic dynamometer with the cable. A magnetic nerve stimulator will be used over the body of the quadriceps muscle to stimulate the muscle.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 5 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion criteria
Subjects in this arm will be in the study for up to 28 days or until discharge from the ICU. They will receive lower extremity muscle stimulation with Niveus medical stimulator, multiple measurement of maximal isometric twitch strength, muscle biopsy with muscle biopsy medication fentanyl, muscle biopsy medication versed, muscle biopsy medication lidocaine, and blood and urine sampling.
Device: Muscle stimulation with Niveus medical stimulator · Device: measurement of maximal isometric twitch strength · Procedure: Muscle Biopsy · Drug: Muscle Biopsy Medication: Lidocaine · Drug: Muscle Biopsy Medication: Versed · Drug: Muscle Biopsy Medication: Fentanyl · Other: Blood and Urine Sampling
Subjects assigned to this arm will be studied for up to 28 days or until discharge and will receive a sham muscle stimulation with Niveus medical stimulator, multiple measurement of maximal isometric twitch strength blood and urine samples, and a muscle biopsy sample with muscle biopsy medication fentanyl, muscle biopsy medication versed, and muscle biopsy medication lidocaine.
Device: measurement of maximal isometric twitch strength · Procedure: Muscle Biopsy · Drug: Muscle Biopsy Medication: Lidocaine · Drug: Muscle Biopsy Medication: Versed · Drug: Muscle Biopsy Medication: Fentanyl · Other: Blood and Urine Sampling · Device: ineffective muscle stimulation
Subjects will be treated five days per week, for 30 minutes each session. Muscle stimulation will be conducted for four seconds every 15 seconds, thus the subjects will undergo four stimulations per minute. Muscle stimulation will be adjusted until there is a visible or palpable bilateral quadriceps contraction.
Quadriceps strength will be measured on the initial day of study approximately every seven days thereafter and on the final day of study participation. For this measurement, patients will remain supine in their bed and the dominant leg will be placed on a frame that will hold the knee at a 60° angle. A cuff will be placed around the ankle and connected to an electronic dynamometer that will record the force generated during the stimulation. The muscle will be stimulated to contract with magnetic stimulators placed over the body of the quadriceps muscle and stimulated at 100% of power output.
This procedure will be done at the end of participation in the study.The biopsy will be performed with a sterile needle, which will be inserted through the skin. A skin incision (approximately 1/4" long) will be made in order to insert the needle. The biopsy procedure yields two small pieces of muscle tissue (200 mg total), each about half the size of the eraser on a pencil. After the biopsy is taken, the incision will be closed using a steri-strip bandage (no stitches are required), and a sterile dressing will be placed over the site to reduce the risk of bleeding.
Biopsy samples will be obtained under local anesthesia (up to 20 milliliters of 1% Lidocaine administered subcutaneously). Lidocaine, a drug to numb your pain will be injected into the skin and muscle tissue. The injection of the numbing medication will be slightly painful and is similar to receiving a shot into your arm for a vaccination. This medication numbs the skin and muscle so that you do not feel pain when the biopsy is obtained.
Also known as: Lidocaine for biopsy
Prior to starting the muscle biopsy, you can receive a drug, Versed, to help you relax during the procedure. 1-2 milligrams of Versed will be administered intravenously (in the vein) through an existing peripheral or central intravenous catheter. This procedure drug is given as needed and can be repeated one time as needed.
Also known as: Versed for biopsy
Prior to starting the muscle biopsy, you can receive a drug, Fentanyl, to make you more comfortable during the procedure. 50-100 micrograms of Fentanyl will be administered intravenously (in the vein) through an existing peripheral or central intravenous catheter. This procedure drug is given as needed and can be repeated one time as needed.
Also known as: Fentanyl for biopsy
Blood and urine samples will be obtained and examined for markers inflammation and muscle catabolism. Sampling will occur at time of entry into study, and then once every 2-4 days and on the final day of participation or the last day of study (day 28). Peripheral blood will be collected from an existing venous line, or by venipuncture, if required. Urine will be collected from an existing catheter or if the patient is able to void on their own then we will provide a specimen cup. There will be no more than 14 ml of blood drawn at any given time point and a collection of 15 ml of urine at each time point.
An investigator will perform range of motion on both legs, five days per week. The range of motion activity will include the investigator helping you bend and straighten each knee approximately 12 times. Rotation of the leg at the hip will also be performed by bending your knee and gently rotating your upper leg in a clockwise and counterclockwise motion. The range of motion will be performed on each leg and repeated five days per week.
Isometric muscle twitch force measured at the start of the study, approximately every seven days thereafter and final day of study.
Measurement of maximal isometric strength will be done by using a dynamometer.
Time frame: Change from days 1, 7, 14, 21, and 28
Change in inflammatory markers on days 1, 7, 14, 21, and 28.
blood and urine will be tested for the markers of inflammation. The following will be tested: (IL)-1β, IL-6, IL-8, IL-10, IL-12, (TNF)α, (IFN)γ, (MCP)-1, (IP)10, (SDF)-1, (MIP)1α, (HMG)B1, procalcitonin, and (CRP).
Time frame: Change from days 1, 7, 14, 21, and 28
Change in immunosuppressive markers on days 1, 7, 14, 21, and 28.
blood and urine will be tested for the markers of immunosuppression. The following will be tested: MDSC phenotype (HLA-DRlow)
Time frame: Change from days 1, 7, 14, 21, and 28
Measurement of key proteins of mitochondrial function using immunohistochemistry and Western blotting
Quadriceps muscle samples will be obtained with percutaneous biopsies following training. Muscle fiber cross-sectional area, myosin heavy chain composition, and changes in atrophy-specific proteins will be assessed using immunohistochemistry and Western blotting, respectively. High-resolution respirometry on permeabilized muscle fibers will be used to measure changes in mitochondrial O2 consumption and muscle bioenergetics. In addition, we will measure key proteins of mitochondrial function and biogenesis.
Time frame: Measurement on day 28
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