The Effect of Standard or Higher Protein Feeding on Indicator Amino Acid Oxidation in ICU Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Indicator amino acid oxidation
Study Overview
Brief Summary
This study will use the indicator amino acid oxidation technique (IAAO) to determine protein oxidation of ICU patients at two protein intakes: 1.3 g/kg/d versus 2.0 g/kg/d.
Detailed Description
Rationale:
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) could provide an alternative to better investigate optimal protein feeding during critical illness.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1.3 g/kg/day followed by 2.0 g/kg/day
Patients in this arm will, on their first test day, receive enteral nutrition containing 1.3 grams of protein per kg of body weight per day followed by 2.0 grams of protein per kg of body weight per day on their second test day.
Intervention: Standard protein enteral nutrition with enteral tracer (Combination Product)
1.3 g/kg/day followed by 2.0 g/kg/day
Patients in this arm will, on their first test day, receive enteral nutrition containing 1.3 grams of protein per kg of body weight per day followed by 2.0 grams of protein per kg of body weight per day on their second test day.
Intervention: High protein enteral nutrition with enteral tracer (Combination Product)
2.0 g/kg/day followed by 1.3 g/kg/day
Patients in this arm will, on their first test day, receive enteral nutrition containing 2.0 grams of protein per kg of body weight per day followed by 1.3 grams of protein per kg of body weight per day on their second test day.
Intervention: Standard protein enteral nutrition with enteral tracer (Combination Product)
2.0 g/kg/day followed by 1.3 g/kg/day
Patients in this arm will, on their first test day, receive enteral nutrition containing 2.0 grams of protein per kg of body weight per day followed by 1.3 grams of protein per kg of body weight per day on their second test day.
Intervention: High protein enteral nutrition with enteral tracer (Combination Product)
Outcomes
Primary Outcomes
Indicator amino acid oxidation
Time Frame: Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission.
Indicator amino acid oxidation expressed as µmol/kg/h
Secondary Outcomes
- 13CO2 excretion in breath (F13CO2)(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected before start of tracer and at end of tracer protocol.)
- Enrichments of urine L-[1-13C]-phenylalanine(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected before start of tracer and at end of tracer protocol.)
- Concentration of plasma phenylalanine(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected before start of tracer and at end of tracer protocol.)
- Enrichments of plasma L-[1-13C]-phenylalanine(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected before start of tracer and at end of tracer protocol.)
- Fecal output and fecal protein content(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected from start of intervention until end of intervention & tracer protocol.)
- Enrichment of breath 13CO2(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected before start of tracer and at end of tracer protocol.)
- CO2 production(Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission. Per test day: collected 2 hours after start of tracer protocol.)