Post Intensive Care Unit SyndromeNUTRI-ICUNCT06119711
Micronutrient Levels and Nutritional Status in Critical Illness
An observational study of Post Intensive Care Unit Syndrome and Malnutrition, run by Frisius Medisch Centrum at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Unit Syndrome, Malnutrition
- How many people
- 79 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 May 2023to 3 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age: 18 years and above.
Who cannot join
- Not proficient in speaking and/or understanding Dutch
- Comorbidity highly affecting gut absorption (e.g. post-bariatric surgery)
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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
- Being tested
- No intervention
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Short stay | Patients admitted to the ICU with a need for mechanical ventilation of less than 48 hours Receives: Other: No intervention | |
| Long stay | Patients admitted to the ICU with a need for mechanical ventilation of 48 hours or more Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at ICU admission
Secondary outcomes (2)
Dietary intake
24-hour dietary recall
Measured: at ICU admission
Physical health
Bioimpedance analysis and ultrasound assessment of quadriceps muscle thickness
Measured: at ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start8 May 2023
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen
- Responsible party
- Principal investigator, Lise Beumeler, Frisius Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119711
- Sponsor's protocol ID
- NL83298.099.22
- Acronym
- NUTRI-ICU
- Status last verified
- Mar 2024
- First submitted
- 3 Jul 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micronutrient Levels and Nutritional Status in Critical Illness
- ClinicalTrials.gov ID
- NCT06119711
- Acronym / sponsor ID
- NUTRI-ICU / NL83298.099.22
- Conditions
- Post Intensive Care Unit Syndrome, Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Collaborators
- University of Groningen
- Study start
- 8 May 2023 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short stay | – | Other: No interventionPatients admitted to the ICU with a need for mechanical ventilation of less than 48 hours |
| Long stay | – | Other: No interventionPatients admitted to the ICU with a need for mechanical ventilation of 48 hours or more |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Age: 18 years and above.
Key exclusion criteria (2 listed)
- Not proficient in speaking and/or understanding Dutch
- Comorbidity highly affecting gut absorption (e.g. post-bariatric surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Long stay, Short stay |
Primary outcome
Number of biomarker deficits at ICU admission
Time frame: 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
2 secondary outcomes
Dietary intake
Time frame: at ICU admission
Physical health
Time frame: at ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Intensive Care Unit Syndrome and Malnutrition, run by Frisius Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of biomarker deficits at ICU admission (time frame: at ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.