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

Malnutrition Clinical Trial

— 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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06023251
• Other study ID #: EC-2023-236
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: March 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: Zenzi Rosseel, PharmD
• Phone: 003224763344
• Email: zenzi.rosseel[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutrition Adequacy	Increase of caloric adequacy (from 58 to 80%) and protein adequacy (from 52 to 80%) in ICU survivors	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.