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New treatment option for Critical Illness
Official title Replacing Protein Via Enteral Nutrition in Critically Ill Patients
ClinicalTrials.gov ID: NCT04475666
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- (on ICU calendar day 4 or the morning of day 5)
- 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.
You likely can't join if
- 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...
- 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...
- 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.
- Pregnancy.
- Burn patients.
See the full eligibility criteria
- (on ICU calendar day 4 or the morning of day 5)
- 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.
- 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...
- 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.
- Pregnancy.
- Burn patients.
- Prisoners or those undergoing forced treatment.
- Patients with hepatic encephalopathy or Child C liver cirrhosis
- Inherited defect of amino acid metabolism.
- Allergies to protein supplement
The study team makes the final eligibility decision.
Where it's taking place
- Jeddah, Jeddah, Saudi Arabia
- Riyadh, Saudi Arabia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jeddah, Jeddah, Saudi Arabia; Riyadh, Saudi Arabia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.