Phase 3
Completed N=100
Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN
Parenteral Nutrition
Source: ClinicalTrials.gov NCT00672854 ↗
Enrolled (actual)
100
Serious AEs
77.0%
Results posted
Aug 2014
Primary outcomePrimary: Number of New Nosocomial Infections After 48 Hrs of Parenteral Nutrition (PN) Between the 2 Groups During Their Hospital Stay — 21; 29 number of nosocomial infections
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of New Nosocomial Infections After 48 Hrs of Parenteral Nutrition (PN) Between the 2 Groups During Their Hospital Stay |
21; 29 | — |
| SECONDARY Number of Days Patients Stayed in ICU During Parenteral Nutrition Between Treatment Groups |
15.2; 17 | — |
| SECONDARY Mean Plasma Concentration of C-reactive Protein in mg/L at Baseline, Day 3 and Day 7 Among the Treatment Groups Will be Measured |
169.67; 152.45; 109.48; 115.33; 122.71; 146.63 | — |
| SECONDARY Mean Plasma Concentration of Tumor Necrosis Factor-alpha, in pg/mL is Measured Between the Two Treatment Groups |
0.12; 0.09; 0.12; 0.09; 0.10; 0.10 | — |
| SECONDARY Mean Change in Plasma Concentration of Cystine in Micromol Per Liter at Baseline, Day 3 and Day 7 Among the Treatment Groups |
82.22; 75.8; 88.65; 93.54; 90.06; 87.7 | — |
| SECONDARY Mean Hospital Blood Glucose (mg/dL) in Diabetic Patients is Measured During Parenteral Nutrition Between the Two Treatment Groups |
128.4; 125 | — |
| SECONDARY Number of Deaths During Parenteral Nutrition Treatment Between Two Treatment Groups During Hospitalization |
5; 4 | — |
| SECONDARY Mean Change in Percentage of Granulocyte Phagocytosis After 7-day Administration of Parenteral Nutrition Between the Two Treatment Groups |
3.86; 6.36 | — |
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) 400 mg/dL
Data sourced from ClinicalTrials.gov (NCT00672854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.