Micronutrient Levels and Nutritional Status in Critical Illness

NCT ID: NCT06119711

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-08

Study Completion Date

2023-10-03

Brief Summary

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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

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Conditions

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Post Intensive Care Unit Syndrome Malnutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Short stay

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

No intervention

Intervention Type OTHER

No intervention

Long stay

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

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Groningen

OTHER

Sponsor Role collaborator

Frisius Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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Lise Beumeler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical Centre Leeuwarden

Leeuwarden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL83298.099.22

Identifier Type: -

Identifier Source: org_study_id

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