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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Many hospitalized patients who are malnourished or not eating receive intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications. We do not know why TPN increases hospital complications, but it may be caused by the high sugar or fat content in TPN solutions.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Baxter Healthcare Corporation
• Treatments: Insulin; Soybean oil, phospholipid emulsion

Criteria

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