NCT07457554 Will the Use of Respiratory Quotient ''RQ'' Improve Treatment Outcomes for Intensive Care Unit (ICU) Patients?
| NCT ID | NCT07457554 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poznan University of Medical Sciences |
| Condition | Nutritional Therapy in an ICU |
| Study Type | INTERVENTIONAL |
| Enrollment | 236 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 236 participants in total. It began in 2024-10-01 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
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,
Frequently Asked Questions
Who can join the NCT07457554 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Nutritional Therapy in an ICU. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07457554 currently recruiting?
Yes, NCT07457554 is actively recruiting participants. Contact the research team at amadeusz.wozniak@ump.edu.pl for enrollment information.
Where is the NCT07457554 trial being conducted?
This trial is being conducted at Poznan, Poland.
Who is sponsoring the NCT07457554 clinical trial?
NCT07457554 is sponsored by Poznan University of Medical Sciences. The principal investigator is Zbigniew Żaba, PhD at University Clinical Hospital in Poznań, ul. Przybyszewskiego 49, Clinical Department of Anesthesiology, Intensive Care, and Pain Management Departments of Emergency Medicine,. The trial plans to enroll 236 participants.