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

Primary Purpose

Acute Respiratory Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

IV amino acids and in-bed cycle ergometry

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

>=18 years old
Requiring mechanical ventilation or high flow nasal cannula (HFNC) with actual or expected total duration of mechanical ventilation or HFNC >48 hours
Expected ICU stay >4 days after enrollment (to permit adequate exposure to the proposed intervention)

Exclusion Criteria:

>120 continuous hours of mechanical ventilation or HFNC before enrollment
Expected death or withdrawal of life-sustaining treatments within 7 days from enrollment
No expectation for any nutritional intake within the subsequent 72 hours
Severe chronic liver disease (MELD score >20) or acute fulminant hepatitis.
Documented allergy to the amino acid intervention
Not ambulating independently prior to ICU admission (use of gait aid permitted)
Pre-existing primary systemic neuromuscular disease (e.g. Guillain Barre)
Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
Pre-existing intracranial or spinal process affecting motor function
Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
Lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury)
Weight >150kg
Pregnant
Incarcerated

Sites / Locations

University of Vermont College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IV amino acids and in-bed cycle ergometry

Arm Description

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

Outcomes

Primary Outcome Measures

6-minute walk distance (6MWD)

Secondary Outcome Measures

Full Information

NCT ID

NCT02822170

First Posted

June 25, 2016

Last Updated

October 24, 2017

Sponsor

University of Vermont

1. Study Identification

Unique Protocol Identification Number

NCT02822170

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Vermont

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV amino acids and in-bed cycle ergometry

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

IV amino acids and in-bed cycle ergometry

Intervention Description

IV amino acids and in-bed cycle ergometry

Primary Outcome Measure Information:

Title

6-minute walk distance (6MWD)

Time Frame

6MWD will be measured near the time that the particioant is being discharged from the hospital, up to 26 weeks after randomization.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: >=18 years old Requiring mechanical ventilation or high flow nasal cannula (HFNC) with actual or expected total duration of mechanical ventilation or HFNC >48 hours Expected ICU stay >4 days after enrollment (to permit adequate exposure to the proposed intervention) Exclusion Criteria: >120 continuous hours of mechanical ventilation or HFNC before enrollment Expected death or withdrawal of life-sustaining treatments within 7 days from enrollment No expectation for any nutritional intake within the subsequent 72 hours Severe chronic liver disease (MELD score >20) or acute fulminant hepatitis. Documented allergy to the amino acid intervention Not ambulating independently prior to ICU admission (use of gait aid permitted) Pre-existing primary systemic neuromuscular disease (e.g. Guillain Barre) Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met) Pre-existing intracranial or spinal process affecting motor function Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment Lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury) Weight >150kg Pregnant Incarcerated

Facility Information:

Facility Name

University of Vermont College of Medicine

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05405

Country

United States

12. IPD Sharing Statement

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

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