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

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).

Study Overview

• Status: Completed
• Conditions: Sepsis; Critical Illness; Nutrition Disorders; Respiratory Failure; Diaphragm Injury; Quadriceps Muscle Atrophy; Calorie Deficiency
• Intervention / Treatment: Other: Caloric delivery will target results of IC measurement.

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Measured Arm; Patients allocated to the measured energy expenditure (group M) will receive the intervention. Caloric delivery will target results of IC measurement.	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.
No Intervention: Estimated Arm; Patients allocated to the estimated energy expenditure (group E) will receive nutrition with caloric intake calculated based on the Penn State equation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator free days (VFD)	The number of days from day 1 to day 28 (of hospital admission) on which the patient was not on the mechanical ventilator. If the patient expired or requires more than 28 days of mechanical ventilation, the value is zero.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calorie and protein adequacy	Nutritional adequacy of caloric and protein delivery is measured as a ratio of the calories and protein received by the patient compared to the calories and protein prescribed during mechanical ventilation. The ratios are determined individually for calories and protein.	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.
Change in quadricep muscle thickness	Evaluation of the change in muscle thickness during study enrollment in correlation with the adequacy of nutrition delivery.	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.
Change in diaphragm muscle thickness	Evaluation of the change in muscle thickness during study enrollment in correlation with the adequacy of nutrition delivery.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Mortality	Expiration of the participant will be classified as "yes" if patient expired during the current hospital admission.	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.
Hospital length of stay	Total number of days patient was admitted to the hospital for the current admission.	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.
Intensive care unit length of stay	Total number of days patient was admitted in the intensive care unit for the current hospital admission.	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.

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Study Chair: Ashley Mullins, MS, Baylor Health Care System; Principal Investigator: Ariel Modrykamien, MD, Baylor Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): October 3, 2019

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: nutrition; sepsis; indirect calorimetry; muscle thickness
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Disease Attributes; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Respiratory Insufficiency; Muscular Atrophy; Critical Illness; Nutrition Disorders
• Other Study ID Numbers: Baylor IRB#017-362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No