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OpenTrials
Completed

NCT Number: NCT06119711

Micronutrient Levels and Nutritional Status in Critical Illness

Rationale: A significant proportion of patients admitted to the Intensive Care Unit (ICU) is unable to fully recover, even when the initial cause of their illness has been treated. Inadequate dietary intake prior to admission and during the recovery phase may leave patients in a frail physical state, limiting rehabilitation potential. Commonly used methods to assess nutritional intake and nutritional status are highly impacted by various disease-related confounders and reporting bias. We hypothesise that a combined assessment of biomarkers in plasma and urine may provide a more accurate overview of nutritional status at ICU-admission.

Objective:

Main: Assess nutrition-related biomarkers in plasma and urine samples at ICU admission

Secondary:

Identify the number of micronutrient deficiencies at ICU admission Compare biomarker profile and dietary intake of short and long-stay ICU patients at baseline Compare subjective dietary intake, nutritional status and muscle thickness between patients with and without micronutrient deficiencies at baseline Study design: Observational study

Study population: Adult patients admitted to the ICU. Two groups will be recruited: patients with a short length of stay (<48 hours) and patients with a longer length of stay (≥48 hours).

Main study parameters: Biomarker status in blood and urine at ICU admission.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In addition to standard care ICU treatment, the following measurements will be performed:

* Within 24 hours after admission blood and urine samples will be collected from existing venous line and urinary catheter * Within 72 hours an ultrasound measurement of the upper leg will be performed. * During ICU stay, when the patient is capable to do so, they will be asked to complete a retrospective dietary intake assessment.

The risks and negative effects of these tests are limited. However, this study asks for a time investment and physical and mental effort of the patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Centre Leeuwarden

Leeuwarden, 8934AD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 years and above.

Exclusion criteria

  • Not proficient in speaking and/or understanding Dutch
  • Comorbidity highly affecting gut absorption (e.g. post-bariatric surgery)

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Number of biomarker deficits at ICU admission

    Time frame: at ICU admission

    Total number of biomarker deficts at ICU admission, based on data collected within 24 hours after admission on:

    Markers general health: haemoglobin (Hb), mean corpuscular volume (MCV), glucose, c-reactive protein (CRP), thyroid stimulating hormone (TSH), creatinine + glomerular filtration rate (eGFR), alanine aminotransferase (ALAT), urea, albumin, total protein, lipid profile Micronutrients: potassium, calcium, sodium, vit B11, vit B1, vit B6, vit B12, vit D, Vit C, ferritin, magnesium, chloride, phosphorus

Secondary outcomes

  1. Dietary intake

    Time frame: at ICU admission

    24-hour dietary recall

  2. Physical health

    Time frame: at ICU admission

    Bioimpedance analysis and ultrasound assessment of quadriceps muscle thickness

Other outcomes

  1. Patient characteristics

    Time frame: at ICU admission

    Patient characteristics at ICU admission (clinical data from patient records)

  2. Clinical data

    Time frame: at ICU admission

    ICU characteristics from electronic patient records

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Collaborators

  • University of Groningen

Registry information

Acronym: NUTRI-ICU

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2023
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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