Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN

This study compares the effect of a soybean oil-based versus an olive oil-based lipid
emulsion in healthy volunteers and in critically ill patients. In healthy volunteers, your
blood sugar levels, blood vessel function, and your ability to fight infections will be
examined. In ICU patients, we examines whether use of the olive oil-based lipid emulsion may
decrease the risk of infection and hospital complications.

Inclusion criteria:

- Age: 18 - 80 years when initiating PN

- In medical/surgical ICU

- Has central venous access to administer PN

- Anticipated to receive PN ≥ 5 days

Exclusion criteria:

- Enrolled in an investigative study within the last 30 days prior to study entry

- Female patients: pregnant or breast feeding

- Has clinical sepsis (defined as mean arterial pressure (MAP) < 60 mmHg on ≥ 2
occasions and unstable BP despite pressor support) within 24 hours prior to study
entry

- Has known cirrhosis or total bilirubin ≥ 10.0 mg/dL

- Has chronic renal failure (defined as requirement for hemodialysis or peritoneal
dialysis therapy), or creatinine ≥ 3.5 mg/dL without continuous renal replacement
therapy (CRRT), or requires acute post-operative dialysis

- Has an active malignancy (defined as requiring chemotherapy, radiation, and/or
surgical intervention within 90 days prior to study entry) (excluding non-melanoma
skin cancer)

- Has known AIDS

- Has a terminal illness (life expectancy < 7 days)

- Has undergone organ transplantation

- Has received PN with lipid within 48 hours prior to study entry

- Has mental disability to understand the scope and possible consequences of the study
and the legally authorized representative is unavailable

- Has a baseline serum triglyceride > 400 mg/dL