Clinical trial NCT03440593: Indirect Calorimetry Usage and Effect in Ventilator-free Days and Muscle Thickness in Septic Ventilated Patients
Official title: Utilization of Indirect Calorimetry for Calculation of Nutritional Goals and Its Effect in Ventilator-free Days and Muscle Thickness in Septic Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Critical Illness
Respiratory Failure
Nutrition Disorders
Calorie Deficiency
Diaphragm Injury
Quadriceps Muscle Atrophy
Keywords: sepsis
nutrition
indirect calorimetry
muscle thickness
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ventilator free days (VFD)
timeFrame: From current hospital admission date until the date of hospital discharge, date of death from any cause, whichever came first, assessed up to 28 days.
Secondary outcomes:
measure: Calorie and protein adequacy
timeFrame: Nutritional adequacy will be assessed from day one of ventilation in all patients until extubation from the MV or date of death, whichever came first, assessed up to 14 days.
measure: Change in quadricep muscle thickness
timeFrame: Quadricep muscle thickness will be measured upon enrollment to the study (within 72 hours of MV) and every 3-5 days with a minimum of two times per 7 days until extubation from the MV or date of death, whichever came first, assessed up to 14 days.
measure: Change in diaphragm muscle thickness
timeFrame: Diaphragm muscle thickness will be measured upon enrollment to the study (within 72 hours of MV) and then every 3-5 days with a minimum of two times per 7 days until extubation from the MV or date of death, whichever came first, assessed up to 14 days.
Other outcomes:
measure: Hospital Mortality
timeFrame: From current hospital admission date until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 24 months.
measure: Hospital length of stay
timeFrame: From current hospital admission date until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 24 months.
measure: Intensive care unit length of stay
timeFrame: From current hospital admission date until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 24 months.
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Ashley Mullins, MS
role: STUDY_CHAIR
affiliation: Baylor Health Care System
name: Ariel Modrykamien, MD
role: PRINCIPAL_INVESTIGATOR
References: