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NCT Number: NCT06023251

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

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Nutrition

Other

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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lotte Buyle, RD

CONTACT

[email protected]

003224763344

Zenzi Rosseel, PharmD

CONTACT

[email protected]

003224763344

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study 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?

Acronym: BrightSide

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2023
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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