Systemic bioavailability of enteral protein-bound versus free amino acid nutrition during intestinal protein malabsorption in critical illness

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study endpoint will be the splanchnic extraction of phenylalanine,<br /><br>calculated from systemic [1-13C]- and L-[ring2H5]-phenylalanine enrichment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the impact of enteral nutrition on whole body<br /><br>protein balance, glucose and insulin concentrations and faecal energy and<br /><br>protein loss as a measure of malabsorption. </p><br>