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Micronutrient Levels and Nutritional Status in Critical Illness

Micronutrient Levels and Nutritional Status in Critical Illness

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06119711
Acronym
NUTRI-ICU
Enrollment
79
Registered
2023-11-07
Start date
2023-05-08
Completion date
2023-10-03
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition, Post Intensive Care Unit Syndrome

Brief summary

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

University of Groningen
CollaboratorOTHER
Frisius Medisch Centrum
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of biomarker deficits at ICU admissionat ICU admissionTotal 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

MeasureTime frameDescription
Dietary intakeat ICU admission24-hour dietary recall
Physical healthat ICU admissionBioimpedance analysis and ultrasound assessment of quadriceps muscle thickness

Other

MeasureTime frameDescription
Patient characteristicsat ICU admissionPatient characteristics at ICU admission (clinical data from patient records)
Clinical dataat ICU admissionICU characteristics from electronic patient records

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026