drugset / Trial / NCT04012333
The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial
Phase 3
Withdrawn
RWTH Aachen University
Clinical Evaluation Research Unit at Kingston General Hospital · collab
RandomizedParallel-groupSingle-blindPrevention
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.
Timeline
- Start
- 2020-06
- Primary completion
- 2022-03
- Completion
- 2022-03
Outcome
Outcome not reported
Stopped: “PI left site”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OLIMEL | Other / unclassified | — | Other |
| Subject | PeriOLIMEL | Unknown | — | Other |