Critically ill patients
Conditions
Interventions
(When early enteral nutrition within 48 h after enrollment is possible) Protein is administered only through the enteral route
(When early enteral nutrition within 48 h after enrollment is possible)
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 years old or older Requiring intensive care Oral intake nutrition is not possible
Exclusion criteria
Exclusion criteria: Enteral nutirion has been initiated before enrollment Withholding or withdrawing of care before enrollment Consent to participate in the trial cannot be obtained Ineligible to participate determined by a clinical physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abilities to perform basic activities of daily living (Barthel Index) at 90 days after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day and 90-day mortality after randomization Quality of life (EQ-5D-5L) at 90 days after randomization Hospital-, ICU-, Ventilator-, RRT-free days up to 90 days after randomization Infectious diseases up to 28 days after randomization Muscle volume at 7 days and 28 days (or at discharge) after randomization, and changes in muscle volume from randomization to 7 days and 28 days (or at discharge) after randomization Changes in abilities to perform basic activities of daily living (Barthel Index) from the initiation of intensive care to 90 days after randomization Severe adverse events up to 90 days after randomization | — |
Countries
Japan
Contacts
Public ContactRyo Yamamoto
Keio University School of Medicine Department of Emergency and Critical Care Medicine
Outcome results
None listed