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

Primary Purpose

Malnutrition

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical Nutrition
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Cohort

    Arm Description

    oral food, enteral nutrition, parenteral nutrition

    Outcomes

    Primary Outcome Measures

    Nutrition Adequacy
    Increase of caloric adequacy (from 58 to 80%) and protein adequacy (from 52 to 80%) in ICU survivors

    Secondary Outcome Measures

    Full Information

    First Posted
    August 18, 2023
    Last Updated
    September 1, 2023
    Sponsor
    Universitair Ziekenhuis Brussel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06023251
    Brief Title
    Improving Nutritional Adequacy of ICU Survivors in a Prospective Interventional Way: the Bright Side Study
    Acronym
    BrightSide
    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?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2026 (Anticipated)
    Study Completion Date
    August 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitair Ziekenhuis Brussel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnutrition

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort
    Arm Type
    Other
    Arm Description
    oral food, enteral nutrition, parenteral nutrition
    Intervention Type
    Other
    Intervention Name(s)
    Clinical Nutrition
    Intervention Description
    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 Outcome Measure Information:
    Title
    Nutrition Adequacy
    Description
    Increase of caloric adequacy (from 58 to 80%) and protein adequacy (from 52 to 80%) in ICU survivors
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zenzi Rosseel, PharmD
    Phone
    003224763344
    Email
    zenzi.rosseel@uzbrussel.be
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lotte Buyle, RD
    Phone
    003224763344
    Email
    lotte.buyle@uzbrussel.be
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elisabeth De Waele, MD PhD
    Organizational Affiliation
    Universitair Ziekenhuis Brussel, Vrije universiteit Brussel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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