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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47682
Enrollment
16
Registered
2018-07-26
Start date
2018-03-27
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

critical illness (aandoening die IC opname nodig maakt) Protein malabsorption Protein uptake

Interventions

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-[3,5-2H
Malabsorption
Nutrition
Protein

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1) Age > 18 and 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

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
Main study endpoint will be the splanchnic extraction of phenylalanine, calculated from systemic [1-13C]- and L-[ring2H5]-phenylalanine enrichment.

Secondary

MeasureTime frame
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.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)