Indirect Calorimetry Usage and Effect in Ventilator-free Days and Muscle Thickness in Septic Ventilated Patients
Completed · Not applicable
Conditions studied: Sepsis, Critical Illness, Respiratory Failure, Nutrition Disorders, Calorie Deficiency, Diaphragm Injury, Quadriceps Muscle Atrophy
In brief
Patients admitted to the ICU with diagnosis of sepsis and requiring mechanical ventilation for at least 24-hours and receiving enteral or parenteral nutrition will be prospectively randomized to one of two arms. Patients allocated to the estimated energy expenditure group will receive nutrition with caloric intake calculated based on the Penn State equation. Patients randomized to the measured group will receive nutrition with caloric intake calculated based on IC measurement present in the GE ventilator. Patients in the estimated group will have IC performed, but these data will not be used for prescription of nutrition. An equal number of beds within the ICU will be allocated to the measured group and the estimated group. The primary objective is to assess whether the utilization of indirect calorimetry for caloric goal calculation results in improvement in muscular structure, and consequent reduction of mechanical ventilation duration in patients with sepsis in comparison to utilizing the Penn State estimation equation for caloric goal calculation. The secondary objective is to assess whether the utilization of indirect calorimetry for caloric goal calculation results in improved adequacy of nutritional delivery in comparison to the adequacy of nutritional delivered when utilizing the Penn State estimation equation. Adult patients (\> 18 years of age) admitted to the hospital with diagnosis of sepsis, and who require mechanical ventilation during hospitalization will be considered. Patients newly ventilated for at least one day but less than three days will be included in the study. Informed consent will be obtained from the legal authorized representative (LAR).
Key facts
- Study ID
- NCT03440593
- Run by
- Baylor Research Institute
- People needed
- 25
- Starts
- 2018-09-10
- Expected to finish
- 2019-10-03
- Last updated by the study team
- 2020-10-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- New Medical ICU admits
- Mechanically ventilated for one day and less than 3 days upon enrollment
- Adults 18 years or older
- Expected length of ICU stay greater than 3 days
- Initiated on nutrition support (parenteral/or enteral nutrition)
- Sepsis diagnosis documented by physician within one day of ICU admit
- Signed informed consent
You may not qualify if…
- Does not meet all criteria of valid indirect calorimetry test for baseline -measurement
- Receiving pulmonary inhaled vasodilator
- Extracorporeal Membrane, Oxygenation (ECMO)
- Pregnancy
- Patients required to be in prone position
- Reintubation
- DNR/AND
- Prisoner
- Employee of BSWH
- Students in contractual agreement with BSWH entity
Where it is running
- Baylor University Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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