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

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822170
• Other study ID #: CHRMS16-540
• Status: Completed
• Phase: N/A
• First received: June 25, 2016
• Last updated: October 24, 2017
• Start date: June 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	University of Vermont College of Medicine	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.