Image

Indicator Amino Acid Oxidation in ICU Patients

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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:

Randomized, counterbalanced, cross-over trial.

Study population:

Adult patients with an unplanned admission to the ICU, who are mechanically ventilated and have an indication for prolonged enteral nutrition.

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 and blood samples will be applied to assess indicator amino acid oxidation.

Main study parameters/endpoints:

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.

Nature and extent of the burden and risks associated with participation, benefit and group

relatedness

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. To avoid overfeeding in the early phase of critical illness, both in terms of calories and protein, full enteral nutrition is provided after three days of gradual increase of intake (i.e., 25-50-75% of targeted intake, on days 1-2-3 respectively). 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.

Eligibility

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

Study details

Critical Illness, Muscle Wasting

NCT06104527

Maastricht University Medical Center

29 April 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.