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

NCT03440593 | Completed

• 1 other identifier: Baylor IRB#017-362
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

sepsis; nutrition; indirect calorimetry; muscle thickness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Calorie and protein adequacy

  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

  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

  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 (3)

• Hospital Mortality

  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

  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

  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.

Study Arms (2)

Measured Arm

EXPERIMENTAL

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.

Estimated Arm

NO INTERVENTION

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

Interventions

Caloric delivery will target results of IC measurement. OTHER

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.

Measured Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Sepsis; Critical Illness; Respiratory Insufficiency; Nutrition Disorders

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Respiration Disorders; Respiratory Tract Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ashley Mullins, MS

  Baylor Health Care System

  STUDY CHAIR

• Ariel Modrykamien, MD

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: February 22, 2018
• Study Start: September 10, 2018
• Primary Completion: May 31, 2019
• Study Completion: October 3, 2019
• Last Updated: October 22, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)