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

NCT06023251 | Recruiting

• 1 other identifier: EC-2023-236
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Cohort

OTHER

oral food, enteral nutrition, parenteral nutrition

Other: Clinical Nutrition

Interventions

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.

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≥ 18 years
• ICU stay ≥ 7 days
• Ward stay ≥ 3 days
• Nutritional therapy not restricted
• Heterogeneous diseases

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Elisabeth De Waele, MD PhD

  Universitair Ziekenhuis Brussel, Vrije universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zenzi Rosseel, PharmD

CONTACT

003224763344; zenzi.rosseel@uzbrussel.be

Lotte Buyle, RD

CONTACT

003224763344; lotte.buyle@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 5, 2023
• Study Start: October 4, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

BE (1)