Micronutrient Levels and Nutritional Status in Critical Illness

Malnutrition Clinical Trial

— NUTRI-ICU  

Official title:

Micronutrient Levels and Nutritional Status in Critical Illness

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06119711
• Other study ID #: NL83298.099.22
• Status: Active, not recruiting
• Start date: May 8, 2023
• Est. completion date: October 8, 2024

Study information

• Verified date: March 2024
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 79
• Est. completion date: October 8, 2024
• Est. primary completion date: May 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Malnutrition
• Post Intensive Care Unit Syndrome

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Netherlands	Medical Centre Leeuwarden	Leeuwarden

Sponsors (2)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden	University of Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient characteristics	Patient characteristics at ICU admission (clinical data from patient records)	at ICU admission
Other	Clinical data	ICU characteristics from electronic patient records	at ICU admission
Primary	Number of biomarker deficits 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	at ICU admission
Secondary	Dietary intake	24-hour dietary recall	at ICU admission
Secondary	Physical health	Bioimpedance analysis and ultrasound assessment of quadriceps muscle thickness	at ICU admission