Critical IllnessOPTICalNCT07343440
Trial on the Impact of Indirect Calorimetry-Guided Nutritional Support on Patient-Centered Outcomes in Critically Ill Patients - The OPTICal Study
A study testing Indirect Calorimetry Group in people with Critical Illness and ICU, run by HEIDEGGER CP at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, ICU
- What is being tested?
- Indirect Calorimetry Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 1 Jan 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to the ICU with the following criteria:
- ≥18 years old
- On Mechanical Ventilation
- Expected ICU length of stay >72 hours
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Recruiting
Geneva University Hospital
Geneva
Claudia Paula Heidegger, Prof., +41223727440, claudia.heidegger@hug.ch
Aude de Watteville, MSc, +41795533998, aude.dewatteville@hug.ch
- Recruiting
GHOL
Nyon
Mallory Moret, Dr. med., +41 (0)22 994 67 47, mallory.moretbochatay@ghol.ch
- Recruiting
Zürich University Hospitals
Zurich
Mattia Müller, Dr. med., 0794184324, mattia.muller@usz.ch
About this study
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
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.
- Conditions
- Critical Illness, ICU
- Being tested
- Indirect Calorimetry Group, Control Group - Formula-Based Group
- Keywords
- Nutrition, Indirect calorimetry, Nutrition therapy, Predictive formula
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Control Group - Formula-Based GroupOther
- Nutritional targets determined using predictive equations (pragmatic, set at local level)
- Escalation as per local protocol
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Indirect Calorimetry Group | Experimental | Not described Receives: Other: Indirect Calorimetry Group |
| Control Group - Formula-Based Group | Active comparator | Not described Receives: Other: Control Group - Formula-Based Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (EQ-5D-5L)
Measured using the EQ-5D-5L: 0-100
Measured: At 3 months after ICU admission
Secondary outcomes (17)
Mortality
Measured: 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
Measured: Up to 28 days after ICU admission
Pressure soar
Measured: 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
Measured: Up to 28 days after ICU admission
Protein deficit in grams
according to the protein target defined by predictive formula
Measured: Up to 28 days after ICU admission
Ventilation-free days
Measured: Measured at day 28 after ICU admission
ICU free-days
Measured: Measured at day 28 after ICU admission
Functional recovery: Bartel Index
Using Barthel Index: 0-100
Measured: 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
Measured: At ICU discharge or up to 28 days after ICU admission and at 3 months after ICU discharge
Readmission and rehospitalization rates
Measured: Until 3-month post-ICU admission
Discharge place
Measured: Until 3 months after ICU admission
Return to work
Measured: Until 3 months after ICU admission
Disability and functioning: WHO Disability Assessment Schedule
Using WHO Disability Assessment Schedule (WHODAS 2.0): 0-48
Measured: At 3-month post ICU admission
Disability and functioning: Clinical Frailty Scale
Using Clinical Frailty Scale (CFS): 1-9
Measured: At 3-month post ICU admission
Disability and functioning: Short-form 12
Using Short-form 12 (SF-12): 0-100
Measured: At 3-month post ICU admission
Disability and functioning: MOCA-5
Using montreal cognitive assessment- 5 min (MOCA-5): 0-15
Measured: At 3-month post ICU admission
Disability and functioning: Patient Health Questionnaire-9
Using Patient Health Questionnaire-9 (PHQ-9): 0-27
Measured: At 3-month post ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jan 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HEIDEGGER CP
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, GHOL Nyon Hospital
- Responsible party
- Sponsor-investigator, HEIDEGGER CP, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343440
- Sponsor's protocol ID
- OPTICal2025
- Acronym
- OPTICal
- Status last verified
- May 2026
- First submitted
- 7 Aug 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07343440
- Acronym / sponsor ID
- OPTICal / OPTICal2025
- Conditions
- Critical Illness, ICU
- Keywords
- Nutrition, Indirect calorimetry, Nutrition therapy, Predictive formula
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- HEIDEGGER CPUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, GHOL Nyon Hospital
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Indirect Calorimetry Group | Experimental | Other: Indirect Calorimetry Group |
| Control Group - Formula-Based Group | Active comparator | Other: Control Group - Formula-Based Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years old
- On Mechanical Ventilation
- Expected ICU length of stay >72 hours
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Intervention Group - Indirect Calorimetry Group |
| Control Group - Formula-Based Group* Nutritional targets determined using predictive equations (pragmatic, set at local level) * Escalation as per local protocol | Other | Control Group - Formula-Based Group |
Primary outcome
Quality of life (EQ-5D-5L)
Time frame: At 3 months after ICU admission
Measured using the EQ-5D-5L: 0-100
17 secondary outcomes
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
Disability and functioning: WHO Disability Assessment Schedule
Time frame: At 3-month post ICU admission
Disability and functioning: Clinical Frailty Scale
Time frame: At 3-month post ICU admission
Disability and functioning: Short-form 12
Time frame: At 3-month post ICU admission
Disability and functioning: MOCA-5
Time frame: At 3-month post ICU admission
Disability and functioning: Patient Health Questionnaire-9
Time frame: At 3-month post ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect Calorimetry Group in people with Critical Illness and ICU, run by HEIDEGGER CP at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Paula Heidegger, Prof. (+41223727440, claudia.heidegger@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (EQ-5D-5L) (time frame: At 3 months after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.