Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in Healthy Volunteers and ICU Patients (TPN)

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT00672854
First received: April 18, 2008
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Parenteral Nutrition
Drug: ClinOleic
Drug: Intralipid
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Studies 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 in Healthy Volunteers and ICU Pts

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Immune function/nosocomial infection rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • endothelial function [ Time Frame: 2-year ] [ Designated as safety issue: No ]
  • inflammatory markers [ Time Frame: 2-year ] [ Designated as safety issue: No ]
  • oxidative stress [ Time Frame: 2-year ] [ Designated as safety issue: No ]
  • autonomic nervous system [ Time Frame: 2-year ] [ Designated as safety issue: No ]
  • insulin sensitivity [ Time Frame: 2-year ] [ Designated as safety issue: No ]
  • hospital mortality [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TPN with Intralipid (30%)
Drug: Intralipid
TPN with Intralipid (30%)
Experimental: 2
TPN with ClinOleic (20%)
Drug: ClinOleic
TPN with ClinOleic (20%)

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

For the healthy volunteer study:

Inclusion Criteria:

  • Healthy males or females, BMI 25 -35 kg/m2, between the ages of 18 and 65 years.

Exclusion Criteria:

  • The patient is pregnant or breast feeding
  • Subjects have or with history of diabetes, hypertension, fasting triglyceride levels > 250 mg/dL, liver disease (ALT 2.5x > upper limit of normal), serum creatinine ≥1.5 mg/dL
  • Smokers or ex-smoker < 3 months of cessation, drug or alcohol abuse
  • Mental condition rendering the subject unable to understand the scope and possible consequences of the study.

For the ICU study:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Emory University

Additional 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
Study First Received: April 18, 2008
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 22, 2014