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 range18 Years – 75 Years
SexALL
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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
Exclusion criteria
✕. 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