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Nutrition and Exercise in Critical Illness (The NEXIS Trial): A Pilot Study and Randomized Trial of Combined Cycle Ergometry and Amino Acids in the ICU

Details

Status

open

Study Type

Interventional

Study Phase

II

Location(s)

The Johns Hopkins Hospital

1800 Orleans St Baltimore, MD 21287

Brief 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.

Eligibility

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