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

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).

Conditions

• Sepsis
• Critical Illness
• Respiratory Failure
• Nutrition Disorders
• Calorie Deficiency
• Diaphragm Injury
• Quadriceps Muscle Atrophy

Interventions

OTHER

Caloric delivery will target results of IC measurement.

The prescribed calories to be delivered will be set to target the measurement obtained from performing indirect calorimetry (IC). IC measures the gas exchange of oxygen consumption and carbon dioxide production to determine the true metabolic needs for cellular respiration. The expenditure of calories will be measured utilizing the gas module incorporated within the General Electric Carescape R860 ventilators.

Sponsors & Collaborators

• Baylor Research Institute

  lead OTHER

Principal Investigators

• Ashley Mullins, MS · Baylor Health Care System

• Ariel Modrykamien, MD · Baylor Health Care System

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-10

Primary Completion

2019-05-31

Completion

2019-10-03

Countries

• United States

Study Locations