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NCT Number: NCT07343440

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

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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Key information

Conditions

Critical Illness Disease Attributes ICU Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospital, Geneva, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indirect Calorimetry Group

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

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

Primary outcomes

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

    Time frame: At 3 months after ICU admission

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

Secondary outcomes

  1. Mortality

    Time frame: Up to 3 months after ICU admission

  2. Nosocomial infection

    Time frame: Up to 28 days after ICU admission

    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

  3. Pressure soar

    Time frame: Up to 28 days after ICU admission

  4. Energy deficit in kcal

    Time frame: Up to 28 days after ICU admission

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

  5. Protein deficit in grams

    Time frame: Up to 28 days after ICU admission

    according to the protein target defined by predictive formula

  6. Ventilation-free days

    Time frame: Measured at day 28 after ICU admission

  7. ICU free-days

    Time frame: Measured at day 28 after ICU admission

  8. Functional recovery: Bartel Index

    Time frame: At ICU discharge or up to 28 days after ICU admission and at 3 months after ICU discharge

    Using Barthel Index: 0-100

  9. 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

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

  10. Readmission and rehospitalization rates

    Time frame: Until 3-month post-ICU admission

  11. Discharge place

    Time frame: Until 3 months after ICU admission

  12. Return to work

    Time frame: Until 3 months after ICU admission

  13. Disability and functioning: WHO Disability Assessment Schedule

    Time frame: At 3-month post ICU admission

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

  14. Disability and functioning: Clinical Frailty Scale

    Time frame: At 3-month post ICU admission

    Using Clinical Frailty Scale (CFS): 1-9

  15. Disability and functioning: Short-form 12

    Time frame: At 3-month post ICU admission

    Using Short-form 12 (SF-12): 0-100

  16. Disability and functioning: MOCA-5

    Time frame: At 3-month post ICU admission

    Using montreal cognitive assessment- 5 min (MOCA-5): 0-15

  17. Disability and functioning: Patient Health Questionnaire-9

    Time frame: At 3-month post ICU admission

    Using Patient Health Questionnaire-9 (PHQ-9): 0-27

Study contacts

Contact information is provided by the study sponsor or research team.

Aude de Watteville, MSc

CONTACT

[email protected]

+41795533998

Claudia Paula Heidegger, Prof.

CONTACT

[email protected]

+41223727440

Sponsors and collaborators

Lead sponsor

HEIDEGGER CP

Other

Collaborators

  • GHOL Nyon Hospital
  • University Hospital, Zürich

Registry information

Official study 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

Acronym: OPTICal

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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