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

May 15, 2026 updated by: HEIDEGGER CP

A Randomized Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
356

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Geneva, Switzerland
        • Recruiting
        • Geneva University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudia Heidegger, Prof.
        • Sub-Investigator:
          • Aude de Watteville, MSc
        • Sub-Investigator:
          • Hannah Wozniak, Dr. med
      • Nyon, Switzerland
      • Zurich, Switzerland
        • Recruiting
        • Zürich University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group - Indirect Calorimetry Group
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
Active Comparator: Control Group - Formula-Based Group
Other: Control Group - Formula-Based Group
  • Nutritional targets determined using predictive equations (pragmatic, set at local level)
  • Escalation as per local protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of life (EQ-5D-5L)
Time Frame: At 3 months after ICU admission
Measured using the EQ-5D-5L: 0-100
At 3 months after ICU admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Up to 3 months after ICU admission
Up to 3 months after ICU admission
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
Up to 28 days after ICU admission
Pressure soar
Time Frame: Up to 28 days after ICU admission
Up to 28 days after ICU admission
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
Up to 28 days after ICU admission
Protein deficit in grams
Time Frame: Up to 28 days after ICU admission
according to the protein target defined by predictive formula
Up to 28 days after ICU admission
Ventilation-free days
Time Frame: Measured at day 28 after ICU admission
Measured at day 28 after ICU admission
ICU free-days
Time Frame: Measured at day 28 after ICU admission
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
Using Barthel Index: 0-100
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
Using Edmonton Symptom Assessment Scale (ESAS) : 0-90
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
Until 3-month post-ICU admission
Discharge place
Time Frame: Until 3 months after ICU admission
Until 3 months after ICU admission
Return to work
Time Frame: Until 3 months after ICU admission
Until 3 months after ICU admission
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
At 3-month post ICU admission
Disability and functioning: Clinical Frailty Scale
Time Frame: At 3-month post ICU admission
Using Clinical Frailty Scale (CFS): 1-9
At 3-month post ICU admission
Disability and functioning: Short-form 12
Time Frame: At 3-month post ICU admission
Using Short-form 12 (SF-12): 0-100
At 3-month post ICU admission
Disability and functioning: MOCA-5
Time Frame: At 3-month post ICU admission
Using montreal cognitive assessment- 5 min (MOCA-5): 0-15
At 3-month post ICU admission
Disability and functioning: Patient Health Questionnaire-9
Time Frame: At 3-month post ICU admission
Using Patient Health Questionnaire-9 (PHQ-9): 0-27
At 3-month post ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HEIDEGGER CP

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Zürich
GHOL Nyon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPTICal2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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