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



Status:Completed
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:10/28/2017
Start Date:June 2016
End Date:August 2017

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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.


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
We found this trial at
1
site
1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
?
mi
from
Burlington, VT
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