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

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Nutrition Disorders; Quadriceps Muscle Atrophy; Respiratory Failure; Critical Illness; Diaphragm Injury; Sepsis; Calorie Deficiency

Treatments: Other: Caloric delivery will target results of IC measurement.

Study type: Interventional

Funder types: Other

Identifiers

NCT03440593

Baylor IRB#017-362

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Measured Arm

Experimental group

Description:

Patients allocated to the measured energy expenditure (group M) will receive the intervention. Caloric delivery will target results of IC measurement.

Treatment:

Other: Caloric delivery will target results of IC measurement.

Estimated Arm

No Intervention group

Description:

Patients allocated to the estimated energy expenditure (group E) will receive nutrition with caloric intake calculated based on the Penn State equation.