跳至主要内容
临床试验/NCT07457554
NCT07457554招募中不适用

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

Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
236
试验地点
1
主要终点
28-day ventilator-free days (VFD)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Control

Active Comparator

干预措施: Standard Treatment (Guideline-Based) (Dietary Supplement)

Research group

Experimental

干预措施: RQ guided nutrition (Dietary Supplement)

结局指标

主要结局

28-day ventilator-free days (VFD)

时间窗: 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.

28-day survival rate

时间窗: 28 days after initial admission to ICU and inclusion in the study.

If the patients survives 28 days after initial admission to ICU and inclusion in the study.

Survival rate until hospital discharge.

时间窗: 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.

Survival rate in an ICU.

时间窗: 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.

次要结局

  • 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.)
  • 28-day survival rate(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.)
  • 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.)
  • Ventilator free days(From initial admission to the ICU and inclusion in the study to discharge from the ICU, assessed up to 120 days from the randomisation.)
  • 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.)

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

ek. Woźniak Amadeusz

MD, specialty Anesthesiology and Intensive Care

Poznan University of Medical Sciences

研究点 (1)

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