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

NCT ID: NCT06023251

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-04

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malnutrition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cohort

oral food, enteral nutrition, parenteral nutrition

Group Type OTHER

Clinical Nutrition

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Elisabeth De Waele

Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elisabeth De Waele, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel, Vrije universiteit Brussel

Locations

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UZ Brussel

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Zenzi Rosseel, PharmD

Role: CONTACT

003224763344

Lotte Buyle, RD

Role: CONTACT

003224763344

Facility Contacts

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Elisabeth De Waele, MD, PhD

Role: primary

+32 (0)2 477 51 76

Other Identifiers

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EC-2023-236

Identifier Type: -

Identifier Source: org_study_id

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