To quantitate the difference in digestion and absorption kinetics of dietary whole protein versus free amino acids in vivo in patients admitted to the ICU suffering from malabsorption.
ID
Source
Brief title
Condition
- Other condition
- Malabsorption conditions
Synonym
Health condition
critical illness (aandoening die IC opname nodig maakt)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoint will be the splanchnic extraction of phenylalanine,
calculated from systemic [1-13C]- and L-[ring2H5]-phenylalanine enrichment.
Secondary outcome
Secondary endpoints include the impact of enteral nutrition on whole body
protein balance, glucose and insulin concentrations and faecal energy and
protein loss as a measure of malabsorption.
Background summary
The importance of the provision of sufficient protein in critical illness is
increasingly recognized. Protein malabsorption seems to be an underestimated
but substantial problem in critically ill patients, limiting the amount of this
important nutrient that actually becomes available within the systemic
circulation. Among several contributors to malabsorption in critical illness,
exocrine pancreatic insufficiency has recently emerged as a regularly occurring
phenomenon during critical illness. Pancreatic insufficiency could lead to
reduced digestion and subsequent uptake of enteral provided proteins. A
proposed solution to this problem could be the use of elementary feeds
containing free amino acids instead of whole protein. Due to the lack of easy
applicable and reproducible tests for protein malabsorption the true efficacy
of these feeds is still unknown. We hypothesize that enteral nutrition
containing free amino acids leads to higher systemic levels of amino acids and
will therefore increase the amount of dietary amino acids available for protein
synthesis.
Study objective
To quantitate the difference in digestion and absorption kinetics of dietary
whole protein versus free amino acids in vivo in patients admitted to the ICU
suffering from malabsorption.
Study design
Randomized, single-blind controlled, single-centre, intervention study.
Intervention
Normal enteral nutrition will be ceased 8 hours before the start of study
participation. 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.
Study burden and risks
Total study participation will take 16 hours, including 8 hours of fasting.
Arterial blood samples will be collected regularly, with 50 ml of blood being
sampled in total, amounting to a maximum of 1.0% of total circulating volume.
All infusions, as well as blood sample collection, will be performed through
indwelling catheters necessary for normal ICU treatment, meaning no lines or
nasogastric tubes will have to be placed for the purposes of the study. Both
isotopically labelled protein and free amino acids have been proven safe for
use in humans and carry no harmful risks for the study participant.
Changes in protein digestion, absorption and metabolism are specific to
critical illness and their impact on the clinical condition and recovery of
patients is severe. Investigating new strategies to modulate these effects are
therefore essential, but require experimental studies in a vulnerable
population. The risks in the present study are minimal whereas the results
could help improve nutritional management in the intensive care.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
1) Age > 18 and < 75 years
2) Faecal weight > 350g/day
3) Critical illness of any origin (e.g. medical, surgical, trauma) requiring admittance on ICU ward.
4) Expected ICU stay for the duration of the study protocol
5) Mechanically ventilated (PaO2/FiO2 ratio of >100 and <300)
6) Nasogastric tube in situ
7) Receiving full enteral nutrition without gastric residual volumes
8) Arterial (any location) line in situ
9) Flexi-seal system in situ
Exclusion criteria
1) 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)
2) Proven (pre-existing) primary pancreatic disease or obstruction of the pancreatic duct of any origin (e.g. pancreatitis, carcinoma).
3) Patients who are moribund (not expected to be in ICU for more than 48 hours
due to imminent death)
4) 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)
5) Absolute contraindication to enteral nutrients (e.g., gastrointestinal [GI] perforation, obstruction or no GI tract access for any reason)
6) Receiving parenteral nutrition.
7) Nasoduodenal or nasojejunal feeding tube
8) Renal dysfunction defined as a serum creatinine >171 *mol/L or a urine output of less than 500 ml/last 24 hours
9) Patients requiring chronic veno-venous hemofiltration
10) Patients on ECMO/ELS
11) Cirrhosis * Child Pugh class C/D liver disease
12) Patients with primary admission diagnosis of burns (>30% body surface area)
13) Weight less than 50 kg or greater than 100 kg
14) Pregnant patients or lactating with the intent to breastfeed
15) Previous randomization in this study
16) Enrolment in any other interventional study
17) Milk/lactose allergy
18) Previous participation in a 13C amino acid tracer study within the last year
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60452.068.17 |