Status:
COMPLETED
Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN
Lead Sponsor:
Emory University
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Parenteral Nutrition
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 ...
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, blo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00672854
Start Date
November 1 2008
End Date
December 1 2010
Last Update
October 17 2018
Active Locations (2)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
2
Emory University Hospital
Atlanta, Georgia, United States, 30322