Protein-bound Versus Free Amino Acid Nutrition During INtestinal Malabsorption in Critical Illness (NCT04791774) | Clinical Trial Compass
CompletedNot Applicable
Protein-bound Versus Free Amino Acid Nutrition During INtestinal Malabsorption in Critical Illness
Netherlands16 participantsStarted 2018-03-27
Plain-language summary
In the current study, we willquantitate the difference in digestion and absorption kinetics of dietary whole protein versus free amino acids in vivo in critically ill patients admitted to the intensive care unit suffering from malabsorption. 16 adult, mechanically ventilated ICU patients with clinical signs of malabsorption (faecal weight \>350 g/day) will be included. All patients will receive a primed continuous intravenous infusion of L-\[ring2H5\]-phenylalanine and L-\[3,5-2H2\]-Tyrosine for the duration of the study period. After reaching an isotopic steady state (1.5 hours), patients will receive either \[1-13C\]- phenylalanine labelled milk protein or free amino acids with an identical constitution and \[1-13C\]-phenylalanine.
Main study endpoint will be the splanchnic extraction of phenylalanine, calculated from systemic \[1-13C\]- and L-\[ring2H5\]-phenylalanine enrichment.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \> 18 and \< 75 years
. Fecal weight \> 350g/day
. Critical illness of any origin (e.g. medical, surgical, trauma) requiring admittance on ICU ward.
. Expected ICU stay for the duration of the study protocol
. Mechanically ventilated (PaO2/FiO2 ratio of \>100 and \<300)
. Nasogastric tube in situ
. Receiving full enteral nutrition without gastric residual volumes
. Arterial (any location) line in situ
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Proven (pre-existing) intestinal disease that potentially limits normal gut function and absorption of nutrients (e.g. IBD, short-bowel, entero-cutaneous fistulas including a surgical enterostomy)
. Proven (pre-existing) primary pancreatic disease or obstruction of the pancreatic duct of any origin (e.g. pancreatitis, carcinoma).
. Patients who are moribund (not expected to be in ICU for more than 48 hours due to imminent death)
. A lack of commitment to full aggressive care during the first week due to severity of illness, comorbidities and potential harm from maximal treatment (anticipated withholding or withdrawing treatments)
. Absolute contraindication to enteral nutrients (e.g., gastrointestinal \[GI\] perforation, obstruction or no GI tract access for any reason)
. Receiving parenteral nutrition.
. Nasoduodenal or nasojejunal feeding tube
. Renal dysfunction defined as a serum creatinine \>171 umol/L or a urine output of less than 500 ml/last 24 hours