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
About this trial
This is an interventional supportive care trial for Malnutrition
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
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
NCT ID
NCT06023251
First Posted
August 18, 2023
Last Updated
September 1, 2023
Sponsor
Universitair Ziekenhuis Brussel
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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