Sepsis Clinical Trial
Official title:
Utilization of Indirect Calorimetry for Calculation of Nutritional Goals and Its Effect in Ventilator-free Days and Muscle Thickness in Septic Mechanically Ventilated Patients
Verified date | January 2019 |
Source | Baylor Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 25 |
Est. completion date | October 3, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Baylor University Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | |
Other | 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. | |
Other | 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. | |
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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. |
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