NCT02822170CompletedNot Applicable
A Pilot Study of Combined Cycle Ergometry and Amino Acids in the ICU
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Vermont
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- 6-minute walk distance (6MWD)
Study Overview
Brief Summary
The purpose of this small pilot study is to refine a combined intervention of IV amino acids and cycle ergometry in critically ill patients, and to gather preliminary data, before proceeding with a larger multi-center RCT. A total of 10 patients will receive the combined intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •>=18 years old
- •Requiring mechanical ventilation or high flow nasal cannula (HFNC) with actual or expected total duration of mechanical ventilation or HFNC >48 hours
- •Expected ICU stay >4 days after enrollment (to permit adequate exposure to the proposed intervention)
Exclusion Criteria
- •>120 continuous hours of mechanical ventilation or HFNC before enrollment
- •Expected death or withdrawal of life-sustaining treatments within 7 days from enrollment
- •No expectation for any nutritional intake within the subsequent 72 hours
- •Severe chronic liver disease (MELD score >20) or acute fulminant hepatitis.
- •Documented allergy to the amino acid intervention
- •Not ambulating independently prior to ICU admission (use of gait aid permitted)
- •Pre-existing primary systemic neuromuscular disease (e.g. Guillain Barre)
- •Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
- •Pre-existing intracranial or spinal process affecting motor function
- •Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
- •Lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury)
- •Weight >150kg
- •Incarcerated
Arms & Interventions
IV amino acids and in-bed cycle ergometry
Experimental
Beginning within 96 hours of ICU admission, participants will receive the following combined intervention:
- IV amino acids (15% solution) delivered by continuous infusion, such that the total enteral and IV protein will be between 2.0-2.5 g/kg/day.
- In-bed cycle ergometry exercise delivered in 45-minute sessions 5 days per week according to a detailed specific protocol that includes a safety check and gradual increases in resistance if the participant is actively cycling.
Intervention: IV amino acids and in-bed cycle ergometry (Other)
Outcomes
Primary Outcomes
6-minute walk distance (6MWD)
Time Frame: 6MWD will be measured near the time that the particioant is being discharged from the hospital, up to 26 weeks after randomization.
Secondary Outcomes
No secondary outcomes reported
Investigators
Renee Stapleton
Associate Professor of Medicine
University of Vermont
Study Sites (2)
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