Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN (TPN2)

Emory University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Parenteral Nutrition

Treatments

Drug: Intralipid, 20% Intravenous Emulsion

Drug: ClinOleic 20% Intravenous Emulsion

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00672854

IRB00007587

TPN (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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