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

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06023251

Collaborator

(none)

100

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malnutrition	Other: Clinical Nutrition	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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?

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2026

Anticipated Study Completion Date :

Aug 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Cohort oral food, enteral nutrition, parenteral nutrition	Other: Clinical Nutrition 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.

Arm

Intervention/Treatment

Other: Cohort

oral food, enteral nutrition, parenteral nutrition

Other: Clinical Nutrition

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.

Outcome Measures

Primary Outcome Measures

Nutrition Adequacy [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universitair Ziekenhuis Brussel

Investigators

Principal Investigator: Elisabeth De Waele, MD PhD, Universitair Ziekenhuis Brussel, Vrije universiteit Brussel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elisabeth De Waele, Head of Department, Universitair Ziekenhuis Brussel

ClinicalTrials.gov Identifier:

NCT06023251

Other Study ID Numbers:

EC-2023-236

First Posted:

Sep 5, 2023

Last Update Posted:

Sep 5, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Malnutrition

Study Results

No Results Posted as of Sep 5, 2023