Indirect Calorimetry Usage and Effect in Ventilator-free Days and Muscle Thickness in Septic Ventilated Patients



Status:Enrolling by invitation
Conditions:Food Studies, Hospital, Hospital, Neurology, Pulmonary
Therapuetic Areas:Neurology, Pharmacology / Toxicology, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:1/18/2019
Start Date:September 10, 2018
End Date:December 2020

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Utilization of Indirect Calorimetry for Calculation of Nutritional Goals and Its Effect in Ventilator-free Days and Muscle Thickness in Septic Mechanically Ventilated Patients

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).

Mechanically ventilated septic patients admitted to the ICU receiving enteral and or
parenteral nutrition will be randomly allocated to one of the aforementioned groups.
Demographic information, parameters obtained from the ventilator, muscle measurements through
ultrasonography, and clinical information, such as time spent on the mechanical ventilation,
time spent in ICU and in the hospital will be collected. Participants will enroll in the
study upon admission to the ICU until one of the following occurs-patient is extubated,
discharged from the ICU, or death with a maximum of 14 days of ICU admission. Upon inclusion,
IC will be assessed at baseline in all patients and then twice weekly. Bedside
ultrasonography of the diaphragm and quadricep muscle thickness will be performed upon
enrollment of the study (within 3 days of MV and within 1 day of study enrollment) and
repeated every 3-5 days with a minimum of twice weekly while on the MV. Severity of illness
score (APACHE IV), cause of sepsis, ventilator data, such as average tidal volumes and
plateau pressures, cumulative and equivalent doses of sedatives (propofol, midazolam,
lorazepam) and analgesics (fentanyl, hydromorphone) will be collected. Presence of delirium
during ventilation, based on ICU-CAM scores will be included, as well.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Dallas, TX
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