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

NCT07343440 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2026-05-19

No results posted yet for this study

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. 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

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

Sponsors & Collaborators

  • University Hospital, Zürich

    collaborator OTHER

  • GHOL Nyon Hospital

    collaborator UNKNOWN

  • HEIDEGGER CP

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-06-01
Completion
2027-09-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07343440 on ClinicalTrials.gov