NCT07343440

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Jan 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Jan 2026Sep 2027

First Submitted

Initial submission to the registry

August 7, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

August 7, 2025

Last Update Submit

January 6, 2026

Conditions

Critical IllnessICU

Keywords

NutritionIndirect calorimetryNutrition therapyPredictive formula

Outcome Measures

Primary Outcomes (1)

  • Quality of life (EQ-5D-5L)

    Measured using the EQ-5D-5L: 0-100

    At 3 months after ICU admission

Secondary Outcomes (17)

  • Mortality

    Up to 3 months after ICU admission

  • Nosocomial infection

    Up to 28 days after ICU admission

  • Pressure soar

    Up to 28 days after ICU admission

  • Energy deficit in kcal

    Up to 28 days after ICU admission

  • Protein deficit in grams

    Up to 28 days after ICU admission

  • +12 more secondary outcomes

Study Arms (2)

Intervention Group - Indirect Calorimetry Group

EXPERIMENTAL
Other: Indirect Calorimetry Group

Control Group - Formula-Based Group

ACTIVE COMPARATOR
Other: Control Group - Formula-Based Group

Interventions

Indirect Calorimetry GroupOTHER

* 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 Group - Indirect Calorimetry Group
Control Group - Formula-Based GroupOTHER

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

Control Group - Formula-Based Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted to the ICU with the following criteria:
  • ≥18 years old
  • On Mechanical Ventilation
  • Expected ICU length of stay \>72 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Geneva University Hospital

Geneva, Switzerland

Location

GHOL

Nyon, Switzerland

Location

Zürich University Hospitals

Zurich, Switzerland

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Claudia Paula Heidegger, Prof.

CONTACT

+41223727440claudia.heidegger@hug.ch

Aude de Watteville, MSc

CONTACT

+41795533998aude.dewatteville@hug.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

August 7, 2025

First Posted

January 15, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

CH(3)