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

Not Applicable

Completed

• Conditions: Acute Respiratory Failure
• Interventions: Other: IV amino acids and in-bed cycle ergometry

• Registration Number: NCT02822170
• Lead Sponsor: University of Vermont

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-25
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-07-04
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IV amino acids and in-bed cycle ergometry	IV amino acids and in-bed cycle ergometry	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.

Primary Outcome Measures

Name	Time	Method
6-minute walk distance (6MWD)	6MWD will be measured near the time that the particioant is being discharged from the hospital, up to 26 weeks after randomization.

Trial Locations

Locations (1)

University of Vermont College of Medicine; 🇺🇸 Burlington, Vermont, United States