The Energy Dose Study
Condition: Critical Illness
MeSH terms: Critical Illness
Intervention: Parenteral Nutrition; Propofol; Clevidipine; Dextrose-containing IV Fluids; Enteral feeding
Intervention description: The PN dose will be written for each 24-hr period taking into account any kilocalories (kcal) provided as part of standard of care from propofol, clevidipine, dextrose-containing IV fluid exceeding 500 mL/day, and enteral feedings.; The PN dose will be written for each 24-hr period taking into account calories provided as lipid emulsion in the sedative propofol (1.1 kcal/mL).; The PN dose will be written for each 24-hr period taking into account calories provided as lipid emulsion in clevidipine (2 kcal/mL).; The PN dose will be written for each 24-hr period taking into account calories provided from dextrose-containing IV fluid orders exceeding 500 mL/day.; Enteral nutrition is caloric intake through the gastrointestinal (GI) tract via food consumed through the mouth or a feeding tube delivering nutrition directly to the stomach or small intestines. The PN dose will be written for each 24-hr period taking into account calories provided from any enteral feedings.
Intervention MeSH terms: Clevidipine; Propofol
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Surgical Intensive Care Unit (SICU); Calories; Total Parenteral Nutrition (TPN); Tube Feeding; Optimum Energy Dose in SICU; Malnutrition; Hospital-acquired Infection

Summary:

      The investigators have designed this single-center Randomized Clinical Trial (RCT) to
      prospectively compare, for the first time, the clinical efficacy of different energy doses in
      intensive care unit (ICU) patients requiring parenteral nutrition (PN) due to intestinal
      failure/dysfunction. This study intends to enroll a total of 60 patients (20 per energy dose
      group) to generate critical preliminary data needed to inform subsequent appropriately
      powered Phase III multicenter trials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed informed consent is in place on the patient's chart

          -  The patient is at least 18 but not more than 90 years of age at time of ICU admission

          -  The patient has a body mass index (BMI) less than 40 kg/m^2

          -  The patient has been admitted to either a medical or surgical (non-neurological) ICU
             and is expected to survive and remain in the ICU for at least 72 hours after entry

          -  There is central venous access for administration of the study PN

          -  The patient's primary physician(s) will allow the investigative team to manage the
             study PN and enteral feedings during the current hospitalization

          -  The patient is expected to require total or partial central venous PN for 7 or more
             subsequent days after entry on a clinical basis

        Exclusion Criteria:

          -  The patient is pregnant

          -  The patient has unresuscitated clinical sepsis, defined as unstable blood pressure
             despite vasopressor support and mean arterial pressure (MAP) < 60 mm Hg on at least 3
             consecutive readings within a 3-hour period during the 24 hours prior to study entry

          -  The patient was admitted to the ICU following trauma or burns

          -  The patient has significant renal dysfunction (defined as serum creatinine > 2.5 mg/dL
             or deemed to have significant acute kidney injury by the primary physicians) and is
             not receiving continuous renal replacement therapy (CRRT) or intermittent hemodialysis

          -  The patient has previously undergone an organ transplantation

          -  The patient has a current malignancy or is currently receiving an active regimen of
             chemotherapy and/or radiotherapy to treat a previously diagnosed malignancy

          -  The patient has a history of HIV/AIDS

          -  The patient has received any investigational drug within 60 days prior to study entry

          -  The patient is unable or unwilling to participate in study procedures such as
             longitudinal blood draws and administration of study nutrient formulations