Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN

NCT ID: NCT00672854

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-12-31

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.

Conditions

Parenteral Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intralipid 20% Intravenous Emulsion

Subjects who require Total Parenteral Nutrition TPN receiving Intralipid 20% (soybean-based)

Group Type: ACTIVE_COMPARATOR

Intralipid, 20% Intravenous Emulsion

Intervention Type: DRUG

It is made up of 20% Soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection

ClinOleic 20% Intravenous Emulsion

Subjects who require Total Parenteral Nutrition TPN receiving ClinOleic 20% (olive oil based)

Group Type: EXPERIMENTAL

ClinOleic 20% Intravenous Emulsion

Intervention Type: DRUG

ClinOleic 20% is a lipid emulsion containing a mixture of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%) corresponding to an essential fatty acid intake of approximately 20% of the total fatty acids intake.

Interventions

ClinOleic 20% Intravenous Emulsion

ClinOleic 20% is a lipid emulsion containing a mixture of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%) corresponding to an essential fatty acid intake of approximately 20% of the total fatty acids intake.

Intervention Type: DRUG

Intralipid, 20% Intravenous Emulsion

It is made up of 20% Soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection

Intervention Type: DRUG

Other Intervention Names

Lipid Emulsion; 20% i.v. fat emulsion

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22488002 (View on PubMed)

Other Identifiers

TPN

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00007587

Identifier Type: -

Identifier Source: org_study_id