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

NCT ID: NCT03440593

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2019-10-03

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Measured Arm

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

Group Type: EXPERIMENTAL

Caloric delivery will target results of IC measurement.

Intervention Type: 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.

Estimated Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashley Mullins, MS

Role: STUDY_CHAIR

Baylor Health Care System

Ariel Modrykamien, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Health Care System

Locations

Baylor University Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

Baylor IRB#017-362

Identifier Type: -

Identifier Source: org_study_id