Micronutrient Levels and Nutritional Status in Critical Illness

NCT06119711 | Completed

• 1 other identifier: NL83298.099.22
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Intensive Care Unit Syndrome; Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dietary intake

  at ICU admission

• Physical health

  at ICU admission

Other Outcomes (2)

• Patient characteristics

  at ICU admission

• Clinical data

  at ICU admission

Study Arms (2)

Short stay

Patients admitted to the ICU with a need for mechanical ventilation of less than 48 hours

Other: No intervention

Long stay

Patients admitted to the ICU with a need for mechanical ventilation of 48 hours or more

Other: No intervention

Interventions

No intervention OTHER

No intervention

Long stay; Short stay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the ICU within six months after start of the study (March-August 2023) will be asked for consent to participate in this study. A maximum of 50 'short stay' (\<48 hours admitted) patients will be included. These patients will only participate in the baseline measurements. Patients that are eligible for the standard post-ICU outpatient clinic at three months (≥48 hours admitted/ventilated) will be invited for additional study measurements at the standard care outpatient visit at three months after admission.

You may qualify if:

• Age: 18 years and above.

You may not qualify if:

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

Sponsors & Collaborators

• Frisius Medisch Centrum: lead
• University of Groningen: collaborator

Study Sites (1)

Medical Centre Leeuwarden

Leeuwarden, 8934AD, Netherlands

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: November 7, 2023
• Study Start: May 8, 2023
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)