N/A
N=1,059
Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients
Critically Ill
Bottom Line
View on ClinicalTrials.gov: NCT01167595 ↗Enrolled (actual)
1,059
Serious AEs
—
Results posted
Apr 2021
Primary outcome: Primary: Percentage of Prescribed Calories From Energy — 32; 34.2; 43.6; 33.6 percentage of prescription
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PEP uP Protocol (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Prescribed Calories From Energy |
32; 34.2; 43.6; 33.6 | — |
| PRIMARY Percentage of Prescribed Protein |
33.6; 34.2; 47.4; 33.6 | — |
| SECONDARY Timeliness of Initiation of EN |
40.7; 33.6; 29.7; 35.2 | — |
| SECONDARY Percentage of Participants With Vomiting |
12; 20; 14; 12 | — |
| SECONDARY Percentage of Participants With Pneumonia |
6; 11; 7; 16 | — |
Summary
Critically ill patients are consistently underfed. Feeding protocols are standardized system tools used to guide nutrition practices, but to date have failed to improve delivery of nutrition. The PEP uP Protocol is a new enhanced feeding protocol. Twenty North American Intensive Care Units (ICUs) will assess baseline nutrition practices. Ten ICUs will be randomized to implement the PEP uP Protocol and educational intervention, and ten will be randomized to continue usual care. Nutrition practices will be reevaluated 6 months after baseline. The investigators hypothesize that the PEP uP Protocol will increase delivery of nutrition, and may ultimately lead to improved survival of critical illness.
Eligibility Criteria
Inclusion Criteria
- Critically ill adults (i.e. >18 years of age)
- Mechanically ventilated before or within the first 6 hours of admission to ICU
Exclusion Criteria
- Nutrition (either EN or Parenteral Nutrition (PN)) started before admission to ICU
- Not intubated within 6 hours of admission to ICU
- Receiving non-invasive ventilation (i.e. mask ventilation) during the first 6 hours of ICU stay
- Moribund (as evidenced by death within 48 hours of admission to ICU)
Data sourced from ClinicalTrials.gov (NCT01167595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.