The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary research question: In critically ill patients with nutrition 'risk factors', what is the effect of providing combined EN/PN to the group prescribed a higher dose (≥2.2 grams/kg/day) of protein/amino acid administration compared to a low group prescribed ≤1.2 gram/kg/day (EN only) on patient's functional recovery as measured by 6-minute walk distance just prior to hospital discharge? The hypothesis: Compared to a control group reflective of usual care prescribing practices and an EN only approach, the administration of a higher dose protein/amino acids using EN and PN to nutritionally high-risk critically ill patients will be associated with improved functional outcome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWTH Aachen University
• Collaborator: Clinical Evaluation Research Unit at Kingston General Hospital

Criteria

Inclusion Criteria:

1. ≥18 years old;

2. Expected to remain mechanically ventilated for an additional 48 hours from screening;

3. And have one or more of the following risk factors that make them at high nutritional risk:

1. Low (≤25) or High BMI (≥35)

2. Moderate to severe malnutrition (as defined by local assessments). We will document the means by which sites are making this determination and capture the elements of the assessment (history of weight loss, history of reduced oral intake, etc.).

3. Frailty (Clinical Frailty Scale 5 or more from proxy)

4. Sarcopenia (SARC-F score of 4 or more from proxy)

5. From point of screening, projected duration of mechanical ventilation >4 days

Exclusion Criteria:

1. >96 continuous hours of mechanical ventilation before enrollment

2. Expected death or withdrawal of life-sustaining treatments within 7 days from screening

3. Pregnancy

4. The responsible clinician feels that the patient either needs low or high protein

5. Absolute contraindication to EN

6. Severe metabolic disorders including electrolyte disorders, uncontrolled hyperglycemia, hyperlipidemia, hypophosphatemia.

7. Severe chronic liver disease (MELD-score >20) or acute fulminant hepatitis.

8. Metabolic disorders involving impaired nitrogen utilization

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

10. Lower extremity injury or impairments that prevents them walking prior to hospital discharge (e.g. amputation, knee/hip injury)

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

12. Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre)

13. Intracranial or spinal process affecting motor function

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