Status:
COMPLETED
Protein-bound Versus Free Amino Acid Nutrition During INtestinal Malabsorption in Critical Illness
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Maastricht University
Conditions:
Intestinal Malabsorption
Critical Illness
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 intensiv...
Detailed Description
Background of the study: The importance of the provision of sufficient protein in critical illness is increasingly recognized. Protein malabsorption seems to be an underestimated but substantial prob...
Eligibility Criteria
Inclusion
- 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
- Flexi-seal system in situ
Exclusion
- 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
- Patients requiring chronic veno-venous hemofiltration
- Patients on ECMO/ELS
- Cirrhosis - Child Pugh class C/D liver disease
- Patients with primary admission diagnosis of burns (\>30% body surface area)
- Weight less than 50 kg or greater than 100 kg
- Pregnant patients or lactating with the intent to breastfeed
- Previous randomization in this study
- Enrolment in any other interventional study
- Milk/lactose allergy
- Previous participation in a 13C amino acid tracer study within the last year
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04791774
Start Date
March 27 2018
End Date
November 30 2019
Last Update
March 10 2021
Active Locations (1)
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1
Maastricht UMC+
Maastricht, Netherlands, 6229HX