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Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in Intensive Care Unit Patients (TPN 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00672854
Recruitment Status : Completed
First Posted : May 6, 2008
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Parenteral Nutrition Drug: ClinOleic Drug: Intralipid Phase 2 Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: StudyComparing 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 Start Date : November 2008
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Total Parenteral nutrition (TPN) given Intralipid 20%
Subjects who require TPN receiving Intralipid (soybean-based)
Drug: Intralipid
TPN with Intralipid (20%)
Experimental: Total parenteral nutrition (TPN) given ClinOleic 20%
TPN subjects receive ClinOleic 20% (olive oil based)
Drug: ClinOleic
TPN with ClinOleic (20%)


Outcome Measures

Primary Outcome Measures :
  1. Rate of Nosocomial Infection Rate [ Time Frame: Up to 28 days post-randomization ]
    Culture-proven infection including: wound, drain, respiratory tract, bloodstream infection (BSI), and urinary tract infections while receiving PN and during current hospitalization after study entry


Secondary Outcome Measures :
  1. Endothelial Function [ Time Frame: 2-year ]
  2. Inflammatory Markers [ Time Frame: 2-year ]
  3. Oxidative Stress [ Time Frame: 2-year ]
  4. Autonomic Nervous System [ Time Frame: 2-year ]
  5. Insulin Sensitivity [ Time Frame: 2-year ]
  6. Hospital Mortality [ Time Frame: 2-year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672854


Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Baxter Healthcare Corporation
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guillermo Umpierrez, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00672854     History of Changes
Other Study ID Numbers: IRB00007587
TPN
First Posted: May 6, 2008    Key Record Dates
Results First Posted: August 1, 2014
Last Update Posted: August 1, 2014
Last Verified: July 2014

Keywords provided by Guillermo Umpierrez, Emory University:
parenteral nutrition
lipid emulsion
nosocomial infection
mortality
endothelial function
inflammatory markers
oxidative stress
immune function
autonomic nervous system
insulin sensitivity
carbohydrate metabolism

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Soybean oil, phospholipid emulsion
Hypoglycemic Agents
Physiological Effects of Drugs
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions