PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS

Summary

The investigators have designed a 2-center, pilot feasibility, randomized controlled trial (PROXIMUS) to determine the feasibility and safety of a larger multi center, randomized open-label trial comparing high protein combined with individualized exercise vs. standard management during the acute phase of critical illness in children. The investigators aim to determine the impact of the intervention on preservation of muscle mass; and functional status at 1 month and 6 months after randomization.

Eligibility

Inclusion Criteria:

1. ICU patients aged 1 year (corrected) to \<18 years
2. Require mechanical ventilation (endotracheal intubation or tracheostomy, or initiation of noninvasive ventilation) in the first 72 hours of PICU admission.
3. Able to consent to participate within 72 hours of initiation of mechanical ventilation initiation.

Exclusion Criteria:

* Patients unable to receive EN, PN, or who are on a specialized diet incompatible with the study intervention
* Fulminant liver failure
* Kidney failure (≥KDIGO Stage 3) without replacement therapy
* Functional Status Scale score at PICU admission \<9
* End of life/redirection of care
* ECMO therapy
* Continuous neuromuscular blockade and/or bedrest is medically or surgically necessitated Participation in a conflicting interventional trial
* High risk of refeeding syndrome
* Inborn errors of metabolism
* High BSA burns.

Conditions5

Locations2 sites

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