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

N/ANot Yet RecruitingNCT07343440

HEIDEGGER CP356 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

356

Conditions

Critical Illness ICU

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Geneva University Hospital

Geneva, Switzerland

GHOL

Nyon, Switzerland

Zürich University Hospitals

Zurich, Switzerland

Outcomes

Primary Outcomes

Quality of life (EQ-5D-5L)

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

Time frame: At 3 months after ICU admission

Secondary Outcomes

Mortality

Time frame: Up to 3 months after ICU admission

Nosocomial infection

Defined as the initiation of a new antibiotic treatment lasting at least 72 hours, associated with a documented diagnosis of infection in the patient's chart

Time frame: Up to 28 days after ICU admission

Pressure soar

Time frame: Up to 28 days after ICU admission

Energy deficit in kcal

according to the energy target defined by IC or predictive formula depending on the randomization group

Time frame: Up to 28 days after ICU admission

Protein deficit in grams

according to the protein target defined by predictive formula

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

Using Barthel Index: 0-100

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

Using Edmonton Symptom Assessment Scale (ESAS) : 0-90

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

Disability and functioning: WHO Disability Assessment Schedule

Using WHO Disability Assessment Schedule (WHODAS 2.0): 0-48