Replacing Protein Via Enteral Nutrition in Critically Ill Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Abdullah International Medical Research Center
About this trial
The investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU day 5 until ICU discharge up to ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.
Eligibility criteria
Qualifiers
Age ≥18-years old
Patient started on enteral nutrition (EN) via nasogastric/orogastric or duodenal or percutaneous endoscopic gastrostomy (PEG) or jejunostomy tubes.
The patient is on invasive mechanical ventilation and unlikely to be discharged from ICU next day.
Disqualifiers
Lack of commitment to full life support or brain death. Patients with "Do Not Resuscitate" order but with commitment to ongoing life support can be enrolled.
Patients on any amount of parenteral nutrition (PN) in ICU at the time of screening, whether PN is used alone or in combination with enteral nutrition. Non-nutritional calories (dextrose, propofol, citrate) not considered as PN.
Patients who received an average protein of more than 0.8g/kg/day in the first 4 ICU days.
Patients being fed entirely through oral route - i.e. those who are eating.
Trial design
Treatments tested in this trial
- Replenish protein group
- Standard protein group
Treatment groups
2,502 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov