MalnutritionBrightSideNCT06023251
Improving Nutritional Adequacy of ICU Survivors in a Prospective Interventional Way: the Bright Side Study
A study testing Clinical Nutrition in people with Malnutrition, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The objective is to increase caloric adequacy in patients who survived critical illness and are admitted to the ward by the use of a pro-active inclusive nutritional strategy including supplemental parenteral and/or enteral nutrition and/or oral nutritional supplements guided by indirect calorimetry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Clinical Nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Oct 2023to 31 Aug 2026
- Phase
- Interventional
- 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
Who may be able to join
- Adult ≥ 18 years
- ICU stay ≥ 7 days
- Ward stay ≥ 3 days
- Nutritional therapy not restricted
- Heterogeneous diseases
Who cannot join
- Patients < 18 years
- ICU < 7 days
- Ward stay < 3 days
- Advanced Care Planning with impact on nutritional therapy
- Patients with palliative care
- Metabolic derangements such as metabolic diseases
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Brussels
Elisabeth De Waele, MD, PhD, +32 (0)2 477 51 76, Elisabeth.DeWaele@uzbrussel.be
About this study
Official title: Does the Use of Supplemental Parenteral/Enteral Nutrition and/or Oral Nutrition Supplements Guided by Indirect Calorimetry Combined With Standard of Care Increases Energy Feeding Adequacy in Patients Who Survived Critical Illness?
The objective is to increase caloric adequacy in patients who survived critical illness and are admitted to the ward by the use of a pro-active inclusive nutritional strategy including supplemental parenteral and/or enteral nutrition and/or oral nutritional supplements guided by indirect calorimetry.
This enables the investigators to address, within a clinical/scientific context, a recently demonstrated but until now relatively neglected 'dark side' of patient care at UZ Brussel, comparable to limited global evidence : iatrogenic malnutrition of ICU survivors. The use of a newly developed clinical pathway and nutrition strategy (oral, enteral and parenteral) led by a single SPoC (Single Point of Contact) for patients surviving intensive care will have a clear objective: to address the nutritional deficit in all patients.
- Conditions
- Malnutrition
- Being tested
- Clinical Nutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical NutritionOther
Nutritional care plan implementation, including
- A step-up and step-down nutritional protocol guided by caloric and protein ratio
- Monitoring plan including daily nutritional intake assessment by a dietician and (para)medical supervision by a nutrition support pharmacist and nurse concerning dysphagia, refeeding syndrome, electrolytes abnormalities and access issues
- Indirect calorimetry measurements to assess metabolic needs and body impedance analysis to assess body composition on regular time points
- Dedicated and specialized dietician and nurse involvement
- Adaptive communication policy (translating to native language) and culturally appropriate food regimens and artificial nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Other | oral food, enteral nutrition, parenteral nutrition Receives: Other: Clinical Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition Adequacy
Increase of caloric adequacy (from 58 to 80%) and protein adequacy (from 52 to 80%) in ICU survivors
Measured: The adequacy will be calculated over the entire ward stay: from date of inclusion till 28 days later or death from any cause, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start4 Oct 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth De Waele, Universitair Ziekenhuis Brussel
- Investigators
- Elisabeth De Waele, MD PhD, Principal investigator, Universitair Ziekenhuis Brussel, Vrije universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023251
- Sponsor's protocol ID
- EC-2023-236
- Acronym
- BrightSide
- Status last verified
- Mar 2024
- First submitted
- 18 Aug 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of Supplemental Parenteral/Enteral Nutrition and/or Oral Nutrition Supplements Guided by Indirect Calorimetry Combined With Standard of Care Increases Energy Feeding Adequacy in Patients Who Survived Critical Illness?
- ClinicalTrials.gov ID
- NCT06023251
- Acronym / sponsor ID
- BrightSide / EC-2023-236
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 5 Sep 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.
The objective is to increase caloric adequacy in patients who survived critical illness and are admitted to the ward by the use of a pro-active inclusive nutritional strategy including supplemental parenteral and/or enteral nutrition and/or oral nutritional supplements guided by indirect calorimetry.
This enables the investigators to address, within a clinical/scientific context, a recently demonstrated but until now relatively neglected 'dark side' of patient care at UZ Brussel, comparable to limited global evidence : iatrogenic malnutrition of ICU survivors. The use of a newly developed clinical pathway and nutrition strategy (oral, enteral and parenteral) led by a single SPoC (Single Point of Contact) for patients surviving intensive care will have a clear objective: to address the nutritional deficit in all patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Other | Other: Clinical Nutritionoral food, enteral nutrition, parenteral nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult ≥ 18 years
- ICU stay ≥ 7 days
- Ward stay ≥ 3 days
- Nutritional therapy not restricted
- Heterogeneous diseases
Key exclusion criteria (7 listed)
- Patients < 18 years
- ICU < 7 days
- Ward stay < 3 days
- Advanced Care Planning with impact on nutritional therapy
- Patients with palliative care
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 |
|---|---|---|
| Clinical NutritionNutritional care plan implementation, including * A step-up and step-down nutritional protocol guided by caloric and protein ratio * Monitoring plan including daily nutritional intake assessment by a dietician and (para)medical supervision by a nutrition support pharmacist and nurse concerning dysphagia, refeeding syndrome, electrolytes abnormalities and access issues * Indirect calorimetry measurements to assess metabolic needs and body impedance analysis to assess body composition on regular time points * Dedicated and specialized dietician and nurse involvement * Adaptive communication policy (translating to native language) and culturally appropriate food regimens and artificial nutrition. | Other | Cohort |
Primary outcome
Nutrition Adequacy
Time frame: The adequacy will be calculated over the entire ward stay: from date of inclusion till 28 days later or death from any cause, whichever came first.
Increase of caloric adequacy (from 58 to 80%) and protein adequacy (from 52 to 80%) in ICU survivors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
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.
Elisabeth De Waele, MD PhD principal investigator
Universitair Ziekenhuis Brussel, Vrije universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Nutrition in people with Malnutrition, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Mar 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zenzi Rosseel, PharmD (003224763344, zenzi.rosseel@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition Adequacy (time frame: The adequacy will be calculated over the entire ward stay: from date of inclusion till 28 days later or death from any cause, whichever came first.). 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 26 Mar 2024.