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Recruiting NCT07343440

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

No phase Interventional Critical Illness ICU

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indirect Calorimetry Group, Control Group - Formula-Based Group.
Who it may be relevant to
Registry conditions: Critical Illness, ICU. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Controlled Trial on the Impact of Indirect Calorimetry-Guided Nutritional Support on Patient-Centered Outcomes in Critically Ill Patients - The OPTICal Study

Overview

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.

Interventions

  • Other 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
  • Other Control Group - Formula-Based Group
    * Nutritional targets determined using predictive equations (pragmatic, set at local level) * Escalation as per local protocol

Primary outcome measures

  • Quality of life (EQ-5D-5L) [Time frame: At 3 months after ICU admission]
Secondary outcome measures (12)
  • Mortality [Time frame: Up to 3 months after ICU admission]
  • Nosocomial infection [Time frame: Up to 28 days after ICU admission]
  • Pressure soar [Time frame: Up to 28 days after ICU admission]
  • Energy deficit in kcal [Time frame: Up to 28 days after ICU admission]
  • Protein deficit in grams [Time frame: Up to 28 days after ICU admission]
  • Ventilation-free days [Time frame: Measured at day 28 after ICU admission]
  • ICU free-days [Time frame: Measured at day 28 after ICU admission]
  • Functional recovery: Bartel Index [Time frame: At ICU discharge or up to 28 days after ICU admission and at 3 months after ICU discharge]
  • Gerneral well-being: Edmonton Symptom Assessment Scale [Time frame: At ICU discharge or up to 28 days after ICU admission and at 3 months after ICU discharge]
  • Readmission and rehospitalization rates [Time frame: Until 3-month post-ICU admission]
  • Discharge place [Time frame: Until 3 months after ICU admission]
  • Return to work [Time frame: Until 3 months after ICU admission]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Switzerland · 3 centers
  • Geneva University Hospital — Geneva
  • GHOL — Nyon
  • Zürich University Hospitals — Zurich

Identifiers

NCT: NCT07343440 · OPTICal2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗