Clinical trial NCT00672854: Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN
Official title: Study Comparing a Soybean Oil-Based vs Olive Oil-Based Lipid Emulsion: Effects on Endothelial Function, Inflammatory Markers, Oxidative Stress, Immune Function,Insulin Sensitivity and Carb Metabolism Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parenteral Nutrition
Keywords: parenteral nutrition
lipid emulsion
nosocomial infection
mortality
endothelial function
inflammatory markers
oxidative stress
immune function
autonomic nervous system
insulin sensitivity
carbohydrate metabolism
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2008-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of New Nosocomial Infections After 48 Hrs of Parenteral Nutrition (PN) Between the 2 Groups During Their Hospital Stay
timeFrame: 2 days after Parenteral Nutrition (up to 28 days post randomization)
Secondary outcomes:
measure: Number of Days Patients Stayed in ICU During Parenteral Nutrition Between Treatment Groups
timeFrame: During Parenteral Nutrition (up to 28 days post randomization)
measure: Mean Plasma Concentration of C-reactive Protein in mg/L at Baseline, Day 3 and Day 7 Among the Treatment Groups Will be Measured
timeFrame: Baseline, Day 3 and Day 7
measure: Mean Plasma Concentration of Tumor Necrosis Factor-alpha, in pg/mL is Measured Between the Two Treatment Groups
timeFrame: Baseline, Day 3 and Day 7
measure: Mean Change in Plasma Concentration of Cystine in Micromol Per Liter at Baseline, Day 3 and Day 7 Among the Treatment Groups
timeFrame: Baseline, Day 3 and Day 7
measure: Mean Hospital Blood Glucose (mg/dL) in Diabetic Patients is Measured During Parenteral Nutrition Between the Two Treatment Groups
timeFrame: During Parenteral Nutrition (up to 28 days post randomization)
measure: Number of Deaths During Parenteral Nutrition Treatment Between Two Treatment Groups During Hospitalization
timeFrame: During Parenteral Nutrition (up to 28 days post randomization)
measure: Mean Change in Percentage of Granulocyte Phagocytosis After 7-day Administration of Parenteral Nutrition Between the Two Treatment Groups
timeFrame: Baseline and 7 days post randomization
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Umpierrez GE, Spiegelman R, Zhao V, Smiley DD, Pinzon I, Griffith DP, Peng L, Morris T, Luo M, Garcia H, Thomas C, Newton CA, Ziegler TR. A double-blind, randomized clinical trial comparing soybean oil-based versus olive oil-based lipid emulsions in adult medical-surgical intensive care unit patients requiring parenteral nutrition. Crit Care Med. 2012 Jun;40(6):1792-8. doi: 10.1097/CCM.0b013e3182474bf9.