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Micronutrient Levels and Nutritional Status in Critical Illness

Completed
Conditions
Malnutrition
Post Intensive Care Unit Syndrome
Interventions
Other: No intervention
Registration Number
NCT06119711
Lead Sponsor
Medical Centre Leeuwarden
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
79
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Short stayNo interventionPatients admitted to the ICU with a need for mechanical ventilation of less than 48 hours
Long stayNo interventionPatients admitted to the ICU with a need for mechanical ventilation of 48 hours or more
Primary Outcome Measures
NameTimeMethod
Number of biomarker deficits at ICU admissionat 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 Outcome Measures
NameTimeMethod
Physical healthat ICU admission

Bioimpedance analysis and ultrasound assessment of quadriceps muscle thickness

Dietary intakeat ICU admission

24-hour dietary recall

Trial Locations

Locations (1)

Medical Centre Leeuwarden

🇳🇱

Leeuwarden, Netherlands

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