A Pilot Study of Combined Cycle Ergometry and Amino Acids in the ICU

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2017

Interventions

  • Other: IV amino acids and in-bed cycle ergometry
    • IV amino acids and in-bed cycle ergometry

Arms, Groups and Cohorts

  • Experimental: IV amino acids and in-bed cycle ergometry
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. >=18 years old 2. Requiring mechanical ventilation or high flow nasal cannula (HFNC) with actual or expected total duration of mechanical ventilation or HFNC >48 hours 3. Expected ICU stay >4 days after enrollment (to permit adequate exposure to the proposed intervention) Exclusion Criteria:

1. >120 continuous hours of mechanical ventilation or HFNC before enrollment 2. Expected death or withdrawal of life-sustaining treatments within 7 days from enrollment 3. No expectation for any nutritional intake within the subsequent 72 hours 4. Severe chronic liver disease (MELD score >20) or acute fulminant hepatitis. 5. Documented allergy to the amino acid intervention 6. Not ambulating independently prior to ICU admission (use of gait aid permitted) 7. Pre-existing primary systemic neuromuscular disease (e.g. Guillain Barre) 8. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met) 9. Pre-existing intracranial or spinal process affecting motor function 10. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment 11. Lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury) 12. Weight >150kg 13. Pregnant 14. Incarcerated

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Vermont
  • Provider of Information About this Clinical Study
    • Principal Investigator: Renee Stapleton, Associate Professor of Medicine – University of Vermont

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