drugset / Trial / NCT02467023

Project 4B: Lower Extremity Strength Training in ICU Patients

NCT02467023 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2015-09
Primary completion
2016-07-07
Completion
2016-07-15

Drugs

EvaluationDrugModalityDoseRoute
Background Fentanyl Other / unclassified 50 ug Intravenous
Background Fentanyl Other / unclassified 100 ug Intravenous
Background Lidocaine Other / unclassified 1 % Subcutaneous
Background Lidocaine Other / unclassified 20 ml Subcutaneous
Background Midazolam Small molecule 1 mg Intravenous
Background Midazolam Small molecule 2 mg Intravenous