Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT03440593
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.
Study:
NCT03440593
Study Brief:
Protocol Section:
NCT03440593