Nutrition and Exercise in Critical Illness

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study proposes a novel early intervention combining Intravenous (IV) amino acids plus in-bed cycle ergometry exercise to improve physical outcomes in critically ill patients. The investigators hypothesize that this innovative approach will improve short-term physical functioning outcomes (primary outcome), as well as amino acid metabolism, body composition, and patient-reported outcomes at 6-month follow-up.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
• Collaborators: Johns Hopkins University; University of Vermont

Criteria

Inclusion Criteria:

1. ≥18 years old.

2. Requiring mechanical ventilation with actual or expected total duration of mechanical ventilation ≥ 48 hours.

3. Expected ICU stay ≥ 4 days after enrollment (to permit adequate exposure to the proposed intervention).

Exclusion Criteria:

1. >96 continuous hours of mechanical ventilation before enrollment.

2. Expected death or withdrawal of life-sustaining treatments within this hospitalization.

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. Metabolic disorders involving impaired nitrogen utilization

7. Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted).

8. Pre-existing primary systemic neuromuscular disease (e.g. Guillain Barre).

9. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met).

10. Intracranial or spinal process affecting motor function

11. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment.

12. Patients in hospital >5 days prior to ICU admission

13. Lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury).

14. Remaining intubated for airway protection only

15. Weight ≥150kg

16. Physician declines patient enrollment

17. Insufficient IV access

18. Pregnant

19. Incarcerated