NUTRI-ICU: Micronutrient Levels and Nutritional Status in Critical Illness

Sponsor
Medical Centre Leeuwarden (Other)
Overall Status
Recruiting
CT.gov ID
NCT06119711
Collaborator
University of Groningen (Other)
100
1
17.1
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Micronutrient Levels and Nutritional Status in Critical Illness
Actual Study Start Date :
May 8, 2023
Anticipated Primary Completion Date :
May 8, 2024
Anticipated Study Completion Date :
Oct 8, 2024

Arms and Interventions

Arm Intervention/Treatment
Short stay

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

Other: No intervention
No intervention

Long stay

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

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. Number of biomarker deficits at ICU admission [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 Outcome Measures

  1. Dietary intake [at ICU admission]

    24-hour dietary recall

  2. Physical health [at ICU admission]

    Bioimpedance analysis and ultrasound assessment of quadriceps muscle thickness

Other Outcome Measures

  1. Patient characteristics [at ICU admission]

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

  2. Clinical data [at ICU admission]

    ICU characteristics from electronic patient records

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical Centre Leeuwarden Leeuwarden Netherlands 8934AD

Sponsors and Collaborators

  • Medical Centre Leeuwarden
  • University of Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lise Beumeler, Dr., Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT06119711
Other Study ID Numbers:
  • NL83298.099.22
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023