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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Replenish protein group
Other interventionFor patients with Body mass index(BMI) \<30, use pre-ICU actual body weight(BW) for the calculation; if unavailable, use weight on ICU admission. For patients with BMI \>=30, use adjusted body weight
Standard protein group
Other interventionFor patients with BMI \<30, use pre-ICU actual BW for the calculation; if unavailable, use weight on ICU admission. For patients with BMI \>=30, use adjusted body weight
Treatment groups
2,502 Participants
are divided into 2 treatment groupsGroup A: Replenish protein groupActive comparator 1 intervention
Group B: Standard protein groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
90 day-all cause mortality
Mortality 90 days post randomization
Time frame
90 daysSecondary outcomes
1
Days alive at day 90 without life support
use of vasopressor/inotropic support, invasive mechanical ventilation and/or renal replacement therapy
Time frame
90 days2
Days alive and out of hospital at day 90
90 day survival after randomization
Time frame
90 days3
Bacteremia until 2 days of ICU stay
Any symptoms of bacteremia
Time frame
until 2 days post ICU.4
New or progression of Skin Pressure Ulcers
anytime during ICU stay
Time frame
ICU stayOther outcomes
1
Safety outcomes during ICU stay
New episode of stage 2 or higher AKI by KDIGO criteria; 2. Pneumonia defined as episodes of newly confirmed pneumonia according to the modified CDC criteria; 3. Grade IV Acute Gastrointestinal injury (AGI)
Time frame
ICU stay2
Minor safety outcomes during ICU stay
Feeding tolerance; Diarrhoea; Refeeding syndrome
Time frame
ICU staySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov