Trial on the Impact of Indirect Calorimetry-Guided Nutritional Support on Patient-Centered Outcomes in Critically Ill Patients

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-09-01

Brief Summary

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This multicentric randomized controlled trial aims to evaluate whether indirect calorimetry (IC)-guided nutritional support improves patient-centered outcomes in critically ill adult patients compared to standard formula-based nutritional strategies. The study includes mechanically ventilated patients expected to remain in the ICU for more than 72 hours. The intervention group will receive nutritional targets based on measured resting energy expenditure using the QNRG+ device, with a gradual escalation of energy delivery following current ESPEN guidelines. The primary outcome is quality of life at 3 months post-ICU admission, assessed using the EQ-5D-5L. Secondary outcomes include functional recovery, muscle preservation, infection rates, and rehospitalization. This study is the first to assess the long-term impact of IC-guided nutrition on recovery and quality of life using a patient-centered approach.

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Detailed Description

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Conditions

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Critical Illness ICU

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Group - Indirect Calorimetry Group

Group Type EXPERIMENTAL

Indirect Calorimetry Group

Intervention Type OTHER

* Nutritional targets measured by IC starting on Day 4
* Repeated IC measurements 2 times weekly performed with the QNRG+ device
* Gradual escalation to 80%-100% caloric coverage by Day 4

Control Group - Formula-Based Group

Group Type ACTIVE_COMPARATOR

Control Group - Formula-Based Group

Intervention Type OTHER

* Nutritional targets determined using predictive equations (pragmatic, set at local level)
* Escalation as per local protocol

Interventions

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Indirect Calorimetry Group

* Nutritional targets measured by IC starting on Day 4
* Repeated IC measurements 2 times weekly performed with the QNRG+ device
* Gradual escalation to 80%-100% caloric coverage by Day 4

Intervention Type OTHER

Control Group - Formula-Based Group

* Nutritional targets determined using predictive equations (pragmatic, set at local level)
* Escalation as per local protocol

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

All patients admitted to the ICU with the following criteria:

* ≥18 years old
* On Mechanical Ventilation
* Expected ICU length of stay \>72 hours

Exclusion Criteria

* Refusal of the family or patient
* Patient transferred from another ICU
* Pregnant patient
* Patient is planned for a withdrawal of care or is actively dying
* Cognitive disorder before ICU
* Patient is in jail
* Patients already enrolled in the ongoing NutriPhyT trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No