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

University of Vermont

Status: Completed

Conditions: Acute Respiratory Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02822170

CHRMS16-540

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

IV amino acids and in-bed cycle ergometry

Experimental group

Description:

Beginning within 96 hours of ICU admission, participants will receive the following combined intervention: 1. 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. 2. 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.

Treatment:

Other: IV amino acids and in-bed cycle ergometry