Nutritional Therapy in an ICURQCalNCT07457554
Will the Use of Respiratory Quotient ''RQ'' Improve Treatment Outcomes for Intensive Care Unit (ICU) Patients?
A study testing RQ guided nutrition and Standard Treatment (Guideline-Based) in people with Nutritional Therapy in an ICU and Critically Ill Patients Requiring Mechanical Ventilation, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Introduction and assumptions of the research project: Patients treated in intensive care units (ICUs) require comprehensive treatment. Nutrition is an important and integral part of this therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nutritional Therapy in an ICU, Critically Ill Patients Requiring Mechanical Ventilation
- What is being tested?
- RQ guided nutrition and Standard Treatment (Guideline-Based)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2024to 31 Oct 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient treated in the ICU
- mechanically ventilated
- covered by universal health insurance
Who cannot join
- ECMO therapy
- mechanical ventilation with an oxygen concentration in the breathing mixture FiO2 > 60%
- breathing independently without the aid of a ventilator
- critically ill patients who are not expected to survive the next 48 hours
- pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
University Clinical Hospital in Poznań, ul. Przybyszewskiego 49, Clinical Department of Anesthesiology, Intensive Care, and Pain Management
Poznan, Wielkopolska, 60-355
Amadeusz Juliusz Woźniak, MD, +48 61 161 3250, amadeusz.wozniak@ump.edu.pl
Amadeusz Juliusz Woźniak, MD
About this study
Official title: Will the Use of Respiratory Quotient "RQ" to Optimize Nutrition Therapy With Indirect Calorimetry Improve Treatment Outcomes for Intensive Care Unit (ICU) Patients?
Introduction and assumptions of the research project:
Patients treated in intensive care units (ICUs) require comprehensive treatment. Nutrition is an important and integral part of this therapy. Both insufficient and excessive calorie intake are associated with poorer prognosis and increased mortality in ICU patients. Furthermore, the caloric requirements of patients in life-threatening conditions in the ICU are characterized by periods of hypo- and hypermetabolism, which, if nutrition is not optimized, expose patients to overfeeding or underfeeding. Therefore, monitoring resting energy expenditure (REE) using indirect calorimetry has become the "gold standard" in the ICU. Previous methods based on mathematical formulas for calculating REE were characterized by insufficient correlation with actual demand. Indirect calorimetry uses measured exhaled carbon dioxide and the concentration of oxygen administered. Then, taking into account patient-dependent parameters such as gender, height, and weight, it indirectly calculates energy expenditure, which corresponds to caloric demand. By dividing the volume of CO2 released by the volume of O2 absorbed, investigators can obtain the respiratory quotient (RQ). This quotient is related to the type of diet and is, for example, 0.7 for fats, 0.8 for proteins, and 1.0 for carbohydrates. Its value also changes with nutritional status. High values may suggest an excessive energy supply (relative to demand), while low values may indicate a calorie deficit. Some authors suggest that the RQ ratio could potentially be used to further optimize nutritional status. Currently, however, due to insufficient research, it is mainly used in clinical practice to assess the accuracy of recording and monitoring calorimetry. This study, is trying to assess the usefulness of RQ for optimizing nutrition in patients treated in the ICU.
Read more
Methodology:
Study group:
This will be a randomized study with a study group and a control group in patients treated in the ICU. All patients participating in the study are patients who, at the time of qualification, are mechanically ventilated and treated in the ICU. These will be patients of both sexes, aged 18-85 years. The control group will be fed under the supervision of indirect calorimetry and REE, in accordance with current ICU nutrition guidelines. In the study group, nutritional preparations will be additionally systematized and selected for each patient depending on their RQ value, and caloric requirements will be controlled by indirect calorimetry and REE, as in the control group. Regular assessments of albumin, total protein, total cholesterol, LDL, HDL, iron, glycemia, Na+, K+, and triglycerides will be conducted, collected along with the routine test package. The primary outcome will be 28-day ventilator-free days (VFD), defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. Secondary outcomes will include 28-day survival, survival to ICU discharge, survival to hospital discharge, duration of mechanical ventilation, and ICU length of stay. The planned total sample size is 236 participants (118 per group).
Expected duration of the study: October 2024 to September 2027 Conditions for inclusion in the study: patients > 18 years of age, treated in the ICU, mechanically ventilated, covered by universal health insurance Conditions for exclusion from the study: ECMO therapy, the need for mechanical ventilation with an oxygen concentration in the breathing mixture FiO2 > 60%, patients breathing independently without the aid of a ventilator, critically ill patients who are not expected to survive the next 48 hours, pregnant women, patients < 18 years of age or > 85 years of age
Reasons for discontinuing the study:
- if, during the course of the study, there are clear indications that one of the groups will experience or worsen final outcomes such as mortality, 28-day mortality, length of stay in the ICU - which would suggest a clear advantage of one of the chosen strategies, along with an increase in the number of patients included in the study, a regular analysis of the current effects of both strategies will be conducted,
- the patient develops hypersensitivity/intolerance to nutritional preparations, with no possibility of switching to another preparation used in the study,
Expected results and their planned subsequent use:
Patients from the study group should achieve faster stabilization of nutritional parameters and fewer episodes of underfeeding and overfeeding. This should translate into improved endpoints such as mortality, length of stay in the ICU, and shorter mechanical ventilation time. In addition, the systematization and algorithms for the use of nutritional products developed during the study can be further used in the department conducting the study and other departments around the world.
- Being tested
- RQ guided nutrition, Standard Treatment (Guideline-Based)
- Keywords
- intensive care unit, ICU, respiratory quotient, RQ, indirect calorimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RQ guided nutritionDietary supplement
In the study group, nutritional preparations will be additionally systematized and selected for each patient depending on their RQ value, and caloric requirements will be controlled by indirect calorimetry and REE, as in the control group.
Standard Treatment (Guideline-Based)Dietary supplement
Standard treatment according to ESPEN guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Dietary Supplement: Standard Treatment (Guideline-Based) |
| Research group | Experimental | Not described Receives: Dietary Supplement: RQ guided nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day ventilator-free days (VFD)
Number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. At least 24 consecutive hours free from invasive mechanical ventilation are required. Participants who die before day 28, remain invasively mechanically ventilated on day 28, or require invasive mechanical ventilation for 28 days or longer will be assigned 0 VFD.
Measured: First 28 days after randomization.
Secondary outcomes (5)
28-day survival rate
Survival status at 28 days after randomization.
Measured: 28 days after randomization.
Survival rate in an ICU.
If the patients survives until discharge from an ICU after initial admission to ICU and inclusion in the study.
Measured: From initial admission to the ICU and inclusion in the study to discharge from the ICU, assessed up to 120 days from the randomisation.
Survival rate until hospital discharge.
: If the patients survives until hospital discharge after initial admission to ICU and inclusion in the study.
Measured: From initial admission to ICU and inclusion in the study to hospital discharge, assessed up to 120 days from the randomisation.
Length of stay in the ICU.
Measured total length of stay in the ICU until discharge from the ICU.
Measured: From initial admission to the ICU and inclusion in the study to discharge from the hospital or death, assessed up to 120 days from the randomisation.
Ventilator-associated pneumonia (VAP)
Occurrence of VAP during ICU stay
Measured: From initial admission to the ICU and inclusion in the study to discharge from the ICU, monitored up to 120 days from the randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Oct 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional Therapy in an ICUStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ek. Woźniak Amadeusz, Poznan University of Medical Sciences
- Investigators
- Zbigniew Żaba, PhD, Study director, University Clinical Hospital in Poznań, ul. Przybyszewskiego 49, Clinical Department of Anesthesiology, Intensive Care, and Pain Management Departments of Emergency Medicine,Amadeusz Juliusz Woźniak, MD, Principal investigator, University Clinical Hospital in Poznań, ul. Przybyszewskiego 49, Clinical Department of Anesthesiology, Intensive Care, and Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457554
- Sponsor's protocol ID
- RQ 447/24
- Acronym
- RQCal
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data may be made available upon reasonable request to the corresponding author, following assessment by the study supervisors and approval by the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will the Use of Respiratory Quotient "RQ" to Optimize Nutrition Therapy With Indirect Calorimetry Improve Treatment Outcomes for Intensive Care Unit (ICU) Patients?
- ClinicalTrials.gov ID
- NCT07457554
- Acronym / sponsor ID
- RQCal / RQ 447/24
- Keywords
- intensive care unit, ICU, respiratory quotient, RQ, indirect calorimetry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 9 Mar 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.
Introduction and assumptions of the research project:
Patients treated in intensive care units (ICUs) require comprehensive treatment. Nutrition is an important and integral part of this therapy. Both insufficient and excessive calorie intake are associated with poorer prognosis and increased mortality in ICU patients. Furthermore, the caloric requirements of patients in life-threatening conditions in the ICU are characterized by periods of hypo- and hypermetabolism, which, if nutrition is not optimized, expose patients to overfeeding or underfeeding. Therefore, monitoring resting energy expenditure (REE) using indirect calorimetry has become the "gold standard" in the ICU. Previous methods based on mathematical formulas for calculating REE were characterized by insufficient correlation with actual demand. Indirect calorimetry uses measured exhaled carbon dioxide and the concentration of oxygen administered. Then, taking into account patient-dependent parameters such as gender, height, and weight, it indirectly calculates energy expenditure, which corresponds to caloric demand. By dividing the volume of CO2 released by the volume of O2 absorbed, investigators can obtain the respiratory quotient (RQ). This quotient is related to the type of diet and is, for example, 0.7 for fats, 0.8 for proteins, and 1.0 for carbohydrates. Its value also changes with nutritional status. High values may suggest an excessive energy supply (relative to demand), while low values may indicate a calorie deficit. Some authors suggest that the RQ ratio could potentially be used to further optimize nutritional status. Currently, however, due to insufficient research, it is mainly used in clinical practice to assess the accuracy of recording and monitoring calorimetry. This study, is trying to assess the usefulness of RQ for optimizing nutrition in patients treated in the ICU.
Methodology:
Study group:
This will be a randomized study with a study group and a control group in patients treated in the ICU. All patients participating in the study are patients who, at the time of qualification, are mechanically ventilated and treated in the ICU. These will be patients of both sexes, aged 18-85 years. The control group will be fed under the supervision of indirect calorimetry and REE, in accordance with current ICU nutrition guidelines. In the study group, nutritional preparations will be additionally systematized and selected for each patient depending on their RQ value, and caloric requirements will be controlled by indirect calorimetry and REE, as in the control group. Regular assessments of albumin, total protein, total cholesterol, LDL, HDL, iron, glycemia, Na+, K+, and triglycerides will be conducted, collected along with the routine test package. The primary outcome will be 28-day ventilator-free days (VFD), defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. Secondary outcomes will include 28-day survival, survival to ICU discharge, survival to hospital discharge, duration of mechanical ventilation, and ICU length of stay. The planned total sample size is 236 participants (118 per group).
Expected duration of the study: October 2024 to September 2027 Conditions for inclusion in the study: patients > 18 years of age, treated in the ICU, mechanically ventilated, covered by universal health insurance Conditions for exclusion from the study: ECMO therapy, the need for mechanical ventilation with an oxygen concentration in the breathing mixture FiO2 > 60%, patients breathing independently without the aid of a ventilator, critically ill patients who are not expected to survive the next 48 hours, pregnant women, patients < 18 years of age or > 85 years of age
Reasons for discontinuing the study:
- if, during the course of the study, there are clear indications that one of the groups will experience or worsen final outcomes such as mortality, 28-day mortality, length of stay in the ICU - which would suggest a clear advantage of one of the chosen strategies, along with an increase in the number of patients included in the study, a regular analysis of the current effects of both strategies will be conducted,
- the patient develops hypersensitivity/intolerance to nutritional preparations, with no possibility of switching to another preparation used in the study,
Expected results and their planned subsequent use:
Patients from the study group should achieve faster stabilization of nutritional parameters and fewer episodes of underfeeding and overfeeding. This should translate into improved endpoints such as mortality, length of stay in the ICU, and shorter mechanical ventilation time. In addition, the systematization and algorithms for the use of nutritional products developed during the study can be further used in the department conducting the study and other departments around the world.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Dietary Supplement: Standard Treatment (Guideline-Based) |
| Research group | Experimental | Dietary Supplement: RQ guided nutrition |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient treated in the ICU
- mechanically ventilated
- covered by universal health insurance
Key exclusion criteria (5 listed)
- ECMO therapy
- mechanical ventilation with an oxygen concentration in the breathing mixture FiO2 > 60%
- breathing independently without the aid of a ventilator
- critically ill patients who are not expected to survive the next 48 hours
- pregnant women
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 |
|---|---|---|
| RQ guided nutritionIn the study group, nutritional preparations will be additionally systematized and selected for each patient depending on their RQ value, and caloric requirements will be controlled by indirect calorimetry and REE, as in the control group. | Dietary supplement | Research group |
| Standard Treatment (Guideline-Based)Standard treatment according to ESPEN guidelines. | Dietary supplement | Control |
Primary outcome
28-day ventilator-free days (VFD)
Time frame: First 28 days after randomization.
Number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. At least 24 consecutive hours free from invasive mechanical ventilation are required. Participants who die before day 28, remain invasively mechanically ventilated on day 28, or require invasive mechanical ventilation for 28 days or longer will be assigned 0 VFD.
5 secondary outcomes
28-day survival rate
Time frame: 28 days after randomization.
Survival rate in an ICU.
Time frame: From initial admission to the ICU and inclusion in the study to discharge from the ICU, assessed up to 120 days from the randomisation.
Survival rate until hospital discharge.
Time frame: From initial admission to ICU and inclusion in the study to hospital discharge, assessed up to 120 days from the randomisation.
Length of stay in the ICU.
Time frame: From initial admission to the ICU and inclusion in the study to discharge from the hospital or death, assessed up to 120 days from the randomisation.
Ventilator-associated pneumonia (VAP)
Time frame: From initial admission to the ICU and inclusion in the study to discharge from the ICU, monitored up to 120 days from the randomisation.
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data may be made available upon reasonable request to the corresponding author, following assessment by the study supervisors and approval by the principal investigator.
Related trials for Nutritional Therapy in an ICU
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.
Zbigniew Żaba, PhD study director
University Clinical Hospital in Poznań, ul. Przybyszewskiego 49, Clinical Department of Anesthesiology, Intensive Care, and Pain Management Departments of Emergency Medicine,
Amadeusz Juliusz Woźniak, MD principal investigator
University Clinical Hospital in Poznań, ul. Przybyszewskiego 49, Clinical Department of Anesthesiology, Intensive Care, and Pain Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RQ guided nutrition and Standard Treatment (Guideline-Based) in people with Nutritional Therapy in an ICU and Critically Ill Patients Requiring Mechanical Ventilation, run by Poznan University of Medical Sciences at 1 site in Poland.
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 3 inclusion and 5 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 Amadeusz Juliusz Woźniak, MD (+48 603 927 222, amadeusz.wozniak@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day ventilator-free days (VFD) (time frame: First 28 days after randomization.). 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 10 Sep 2026.