To assess the effect of enteral feeding with higher protein content compared to standard protein content on indicator amino acid oxidation in ICU patients.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Eiwitbehoefte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is indicator amino acid oxidation after enteral feeding
with a standard or higher protein content, determined using the Indicator Amino
Acid Oxidation (IAAO) method by measuring 13CO2 enrichment in expired breath
and enrichment of L-[1-13C]-phenylalanine in plasma and urine.
Secondary outcome
To determine carbon dioxide production, 13CO2 production, plasma and urine
L-[1-13C]-phenylalanine enrichments, plasma phenylalanine concentration, and
fecal output and protein content in ICU patients when applying the IAAO
technique.
Background summary
While protein administration guidelines for critical care are available from
international organizations such as ASPEN and ESPEN, they vary greatly in their
recommended dose and are based on relatively low-quality evidence. The
Indicator Amino Acid Oxidation (IAAO) technique has been developed as a more
practical and non-invasive tool to assess protein metabolism that can be used
in vulnerable populations. Application of the IAAO technique in patients
admitted to the Intensive Care Unit (ICU) enables to better investigate optimal
protein feeding during critical illness.
Study objective
To assess the effect of enteral feeding with higher protein content compared to
standard protein content on indicator amino acid oxidation in ICU patients.
Study design
Randomized, counterbalanced, cross-over trial.
Intervention
Subjects will undergo two test days in randomized order during which they
receive either enteral feeding according to a standard protein dose (1.3
g/kg/d) or a higher protein dose (2.0 g/kg/d). Continuous feeding of
L-[1-13C]-phenylalanine combined with breath, urine, fecal and blood samples
will be applied to assess indicator amino acid oxidation.
Study burden and risks
The overall risk of the study is negligible. The current study compares the
effect of two nutritional compositions, that fall within the recommendations of
international guidelines on ICU nutrition, on protein metabolism following ICU
admission. As muscle wasting and increased protein requirements occur
especially during the early phase of critical illness, the intervention has to
be initiated at this stage. To avoid overfeeding in the early phase of critical
illness, full enteral nutrition is provided after three days of gradual
increase of intake. Sampling of breath, urine, feces and plasma does not bring
additional risks for this population. Our department has an extensive
background in amino acid stable isotope methodology, assessment of 13CO2
enrichment in expired breath samples, and assessment of carbon dioxide
production by indirect calorimetry. Since no associated risks are involved for
either of the interventions, and there is potential to improve care for ICU
patients if the study is able to show a benefit of one treatment over the
other, we believe it is both ethical and justified to perform the study in this
patient group.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
• >= 18 years old
• Unplanned admission to the ICU
• Mechanically ventilated
• Start of enteral nutrition within 2 days of intubation
• >= 3 days on enteral nutrition
• Expected remaining ICU stay on mechanical ventilation of >= 2 days
Exclusion criteria
• Contra-indication for enteral nutrition at the discretion of the treating
physician • Feeding intolerance during incremental feeding protocol • Moribund
or withholding of treatment • On extracorporeal membrane oxygenation (ECMO) •
Presence of chest drains, pneumothorax, tracheoesophageal fistula or
subcutaneous emphysema • Kidney failure AND a *no dialysis*-code on admission •
Hepatic encephalopathy (West Haven criteria 3-4) • BMI < 18 kg/m2
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 | NL84098.000.23 |