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

October 24, 2017 updated by: Renee Stapleton, University of Vermont
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05405
        • University of Vermont College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: IV amino acids and in-bed cycle ergometry
IV amino acids and in-bed cycle ergometry

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

June 25, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

July 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRMS16-540

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Respiratory Failure

Clinical Trials on IV amino acids and in-bed cycle ergometry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe