Nutrition and Exercise in Critical Illness

Completed · Phase 2

Conditions studied: Acute Respiratory Failure

In brief

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.

Key facts

Study ID

NCT03021902

Run by

Clinical Evaluation Research Unit at Kingston General Hospital

People needed

115

Starts

2017-09-28

Expected to finish

2025-06-23

Last updated by the study team

2025-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years old.
• Requiring mechanical ventilation with actual or expected total duration of mechanical ventilation ≥ 48 hours.
• Expected ICU stay ≥ 4 days after enrollment (to permit adequate exposure to the proposed intervention).

You may not qualify if…

• >96 continuous hours of mechanical ventilation before enrollment.
• Expected death or withdrawal of life-sustaining treatments within this hospitalization.
• 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.
• Metabolic disorders involving impaired nitrogen utilization
• Not ambulating independently prior to illness that lead 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).
• Intracranial or spinal process affecting motor function
• Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment.
• Patients in hospital >5 days prior to ICU admission
• Lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury).
• Remaining intubated for airway protection only
• Weight ≥150kg
• Physician declines patient enrollment
• Insufficient IV access
• Pregnant
• Incarcerated
• Patients with acute kidney injury (AKI) as defined by meeting any of the KDIGO criteria (below) and not receiving renal replacement therapy:
• Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours or
• Increase in serum creatinine to ≥ 1.5 times baseline** or
• Urine volume <0.5 ml/kg/h for 6 hoursⴕ

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Montefiore Albert Einstein College of Medicine — The Bronx, New York, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Vermont College of Medicine — Burlington, Vermont, United States
• Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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