Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)
Condition: Critical Illness; Acute Respiratory Failure
MeSH terms: Respiratory Insufficiency; Overweight; Critical Illness
Intervention: Olimel (5.7%E / N9E)
Intervention description: OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Randomized trial; Parental nutrition; Enteral nutrition; Intensive care unit; BMI < 25 or ≥ 35

Summary:

      The specific aim of the proposed study is to conduct a pilot study involving 160
      critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of
      America, Belgium and France in order to:

      Specific Aims

        -  Confirm that we can achieve a clinically significant difference in calorie and protein
           intake between the two intervention groups.

        -  Estimate recruitment rate i.e. number of eligible and enrolled patients per month per
           site.

        -  Evaluate the safety, tolerance, and logistics around providing supplemental PN in the
           study population in the context of a multicenter trial, e.g.

             -  To ensure adequate glycemic control in both groups.

             -  To ensure that the other metabolic consequences of the feeding strategies are
                minimized.

             -  To establish adequate compliance with study protocols and completion of case report
                forms

      A secondary aim of this pilot study will be:

      • To explore the effect of differential effects of calorie and protein delivery on muscle and
      mass function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Critically ill adult patient (≥ 18 years) admitted to ICU

          -  Has acute respiratory failure (ARF) i.e. expected to remain mechanically ventilated
             for more than 48 hours

          -  Expected ICU dependency of 5 or more days

          -  On or expected to initiate enteral nutrition within 7 days of ICU admission

          -  BMI <25 or ≥ 35 based on pre-ICU actual or estimated dry weight

        Exclusion Criteria:

          -  >72 hours from admission to ICU to time of consent

          -  Not expected to survive an additional 48 hrs from screening evaluation

          -  A lack of commitment to full aggressive care (anticipated withholding or withdrawing
             treatments in the first week but isolated DNR acceptable)

          -  Patients already receiving PN at screening

          -  Absence of All gastrointestinal risk factors, defined as:

               1. High Apache II Score (>20)

               2. On more than 1 vasopressor or increasing doses or vasopressors

               3. Receiving continuous infusion of narcotics

               4. High nasogastric/orogastric output (>500 mL over 24 hours)

               5. Recent surgery involving esophagus, stomach, or small bowel OR peritoneal
                  contamination with bowel contents

               6. Pancreatitis

               7. Multiple gastrointestinal investigations

               8. Recent history of diarrhea/C. Difficile

               9. Surgical patients with future surgeries planned

              10. Ruptured or dissected abdominal aortic aneurysm

          -  Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma

          -  Pregnant or lactating patients

          -  Patients with clinical fulminant hepatic failure

          -  Patients with Cirrhosis Child's Class C Liver Disease (except those on a transplant
             list or transplantable)

          -  Dedicated port of central line not available

          -  Known allergy to study nutrients (soy, eggs or olive products)

          -  Enrolment in another industry sponsored ICU intervention study