Indicator Amino Acid Oxidation in ICU Patients

NCT06104527 | Completed

• 1 other identifier: NL84098.000.23
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Muscle Wasting

Keywords

Dietary Protein; Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• Indicator amino acid oxidation

  Indicator amino acid oxidation expressed as µmol/kg/h

  Collected at standard vs higher protein administration, on test day 1 and 2 (depending on randomisation order), during the first week of ICU admission.

Secondary Outcomes (7)

• 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 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.

• 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.

• 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.

Study Arms (2)

1.3 g/kg/day followed by 2.0 g/kg/day

OTHER

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.

Combination Product: Standard protein enteral nutrition with enteral tracer; Combination Product: High protein enteral nutrition with enteral tracer

2.0 g/kg/day followed by 1.3 g/kg/day

OTHER

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.

Combination Product: Standard protein enteral nutrition with enteral tracer; Combination Product: High protein enteral nutrition with enteral tracer

Interventions

Standard protein enteral nutrition with enteral tracer COMBINATION_PRODUCT

Enteral nutrition with standard (1.3 g/kg/d) protein provision, given via a nasogastric tube. An oral L-\[1-13C\]-phenylalanine tracer is given as co-intervention. Use of an enterally given tracer is necessary to determine indicator amino acid oxidation.

1.3 g/kg/day followed by 2.0 g/kg/day; 2.0 g/kg/day followed by 1.3 g/kg/day

High protein enteral nutrition with enteral tracer COMBINATION_PRODUCT

Enteral nutrition with high (2.0 g/kg/d) protein provision, given via a nasogastric tube. An oral L-\[1-13C\]-phenylalanine tracer is given as co-intervention. Use of an enterally given tracer is necessary to determine indicator amino acid oxidation.

1.3 g/kg/day followed by 2.0 g/kg/day; 2.0 g/kg/day followed by 1.3 g/kg/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Luc van Loon, Ph.D.

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 27, 2023
• Study Start: October 30, 2023
• Primary Completion: March 23, 2026
• Study Completion: March 23, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE

Locations

NL (1)