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Improving Nutritional Adequacy of ICU Survivors in a Prospective Interventional Way: the Bright Side Study

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?

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06023251
Acronym
BrightSide
Enrollment
100
Registered
2023-09-05
Start date
2023-10-04
Completion date
2026-08-31
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Brief 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. 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.

Interventions

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.

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult ≥ 18 years * ICU stay ≥ 7 days * Ward stay ≥ 3 days * Nutritional therapy not restricted * Heterogeneous diseases

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Nutrition AdequacyThe 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

Countries

Belgium

Contacts

Primary ContactZenzi Rosseel, PharmD
zenzi.rosseel@uzbrussel.be003224763344
Backup ContactLotte Buyle, RD
lotte.buyle@uzbrussel.be003224763344

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026