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 |
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.
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
Burlington, Vermont 05401
802-656-8990
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