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Will the Use of Respiratory Quotient ''RQ'' Improve Treatment Outcomes for Intensive Care Unit (ICU) Patients?

Will the Use of Respiratory Quotient "RQ" to Optimize Nutrition Therapy With Indirect Calorimetry Improve Treatment Outcomes for Intensive Care Unit (ICU) Patients?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07457554
Acronym
RQCal
Enrollment
236
Registered
2026-03-09
Start date
2024-10-01
Completion date
2027-10-31
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill Patients Requiring Mechanical Ventilation, Nutritional Therapy in an ICU

Keywords

intensive care unit, ICU, respiratory quotient, RQ, indirect calorimetry

Brief 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. 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: 1. 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, 2. 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.

Interventions

DIETARY_SUPPLEMENTRQ guided nutrition

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 according to ESPEN guidelines.

Sponsors

Poznan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* patient treated in the ICU * mechanically ventilated * covered by universal health insurance

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
28-day ventilator-free days (VFD)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.

Secondary

MeasureTime frameDescription
28-day survival rate28 days after randomization.Survival status at 28 days after randomization.
Survival rate in an ICU.From initial admission to the ICU and inclusion in the study to discharge from the ICU, assessed up to 120 days from the randomisation.If the patients survives until discharge from an ICU after initial admission to ICU and inclusion in the study.
Survival rate until hospital discharge.From initial admission to ICU and inclusion in the study to hospital discharge, assessed up to 120 days from the randomisation.: If the patients survives until hospital discharge after initial admission to ICU and inclusion in the study.
Length of stay in the ICU.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.Measured total length of stay in the ICU until discharge from the ICU.
Ventilator-associated pneumonia (VAP)From initial admission to the ICU and inclusion in the study to discharge from the ICU, monitored up to 120 days from the randomisation.Occurrence of VAP during ICU stay

Countries

Poland

Contacts

CONTACTAmadeusz Juliusz Woźniak, MD
amadeusz.wozniak@ump.edu.pl+48 603 927 222
CONTACTUniversity Clinical Hospital in Poznań
anestezjologiap@usk.poznan.pl+48 61 161 3250
STUDY_DIRECTORZbigniew Żaba, PhD

University Clinical Hospital in Poznań, ul. Przybyszewskiego 49, Clinical Department of Anesthesiology, Intensive Care, and Pain Management Departments of Emergency Medicine,

PRINCIPAL_INVESTIGATORAmadeusz Juliusz Woźniak, MD

University Clinical Hospital in Poznań, ul. Przybyszewskiego 49, Clinical Department of Anesthesiology, Intensive Care, and Pain Management

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026