A Randomized Trial of Combined Cycle Ergometry and Amino Acids in the ICU
The trial is registered at ClinicalTrials.gov (NCT03021902)
Background: Between 13 and 20 million people worldwide receive life support in intensive care units (ICUs) annually. More than 750,000 Americans require mechanical ventilation in an intensive care unit (ICU) annually. With recent medical and health care advancements, there has been a rapid increase in ICU survivors. However, ICU survivors frequently experience significant post-ICU morbidities, most often physical morbidities including muscle weakness and impairments in physical functioning that can persist for years. The urgent need to develop new strategies to improve physical recovery of ICU patients has clearly been recognized by the American Association of Critical Care Nurses, American Thoracic Society, and Society of Critical Care Medicine.
The evaluation of an innovative strategy that involves the the combination of intravenous (IV) amino acid supplementation and early-in-bed cycle ergometry in the ICU is novel and potentially very important for ICU survivors. Recent randomized trials (RCTs) have shown that treatment solely based on the increase of calories in ICU patients had no significant improvements on outcomes. In one study, combined exercise and supplementation in elderly patients increased muscle strength by 40% over exercise alone and by 130% over supplementation alone. Therefore, there is an importance in developing innovative strategies that improve physical recovery of ICU patients and this application challenges the current paradigm of bed rest/immobility for ICU patients through use of in-bed cycle ergometry exercise and amino acid supplementation.
Objectives: The purpose of this study is to demonstrate that the combination of intravenous (IV) amino acid supplementation and early-in-bed cycle ergometry have an improvement on the physical functioning, health related quality of life and health care utilization of an ICU survivor.
Study Population: A total of 142 patients the age of 18 years and older requiring mechanical ventilation will be recruited from 4 medical centers to participate in the study.
Study Design: A multi-centered Phase II randomized controlled trial, with blinded outcomes assessment of a combination of intravenous (IV) amino acid supplementation and early-in-bed cycle ergometry exercise versus usual care in ICU patients requiring mechanical ventilation.
Study Sites: Patient recruitment from 4 large hospitals: The University of Vermont Medical Center (UVMMC), Johns Hopkins University (JHI), Harbview Medical Center (HMC) and Wake Forest Baptist Medical Center (WFUBMC)
Outcomes: Improve in-hospital muscle strength and performance-based physical functioning outcomes in critically ill patients, using a primary endpoint of six-minute walk distance (6MWD) at hospital discharge. Secondary endpoints include the following: improve physical functioning, health-related quality of life, and healthcare utilization at 6 months after study enrollment.
Significance: Moreover, as the baby boomer generation ages, the number of patients requiring ventilation is anticipated to rise dramatically, with an 80% increase projected between the years 2000 and 2026. With ongoing advancements in the medical and health care fields, there will also be a rapid increase in ICU survivors. Therefore, there is an urgent need to develop novel strategies that may benefit the lives of ICU survivors; this specifically includes improvement of the following: (1) physical functioning at hospital discharge; (2) reduce muscle wasting with improved amino acid metabolism and protein synthesis in-hospital; and (3) improve health-related quality of life.
Renee Stapleton, MD, PhD, Principal Investigator
Janet Overvelde, Project Leader