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Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN (TPN2)

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ClinicalTrials.gov Identifier: NCT00672854
Recruitment Status : Completed
First Posted : May 6, 2008
Results First Posted : August 1, 2014
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Guillermo Umpierrez, MD, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Parenteral Nutrition
Interventions Drug: ClinOleic 20% Intravenous Emulsion
Drug: Intralipid, 20% Intravenous Emulsion
Enrollment 100
Recruitment Details The study was conducted at Grady Memorial Hospital, a major urban teaching hospital affiliated with Emory University and at Emory University Hospital, a tertiary referral academic institution in Atlanta, Georgia.
Pre-assignment Details A total of 100 patients were randomized to either soybean oil–based (intralipid 20%) parenteral nutrition or olive oil–based (ClinOleic 20%) parenteral nutrition for up to 28 days. A total of 49 patients received soybean oil–based parenteral nutrition and a total of 51 patients received olive oil–based lipid emulsion in parenteral nutrition
Arm/Group Title Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Hide Arm/Group Description

TPN subjects receive Intralipid (soybean-based)

Intralipid: TPN with Intralipid (20%)

TPN subjects receive ClinOleic 20% (olive oil based)

ClinOleic: TPN with ClinOleic (20%)

Period Title: Overall Study
Started 49 51
Completed 49 51
Not Completed 0 0
Arm/Group Title Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20% Total
Hide Arm/Group Description

TPN subjects receive Intralipid (soybean-based)

Intralipid: TPN with Intralipid (20%)

TPN subjects receive ClinOleic 20% (olive oil based)

ClinOleic: TPN with ClinOleic (20%)

Total of all reporting groups
Overall Number of Baseline Participants 49 51 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 51 participants 100 participants
51.3  (15) 46.4  (19) 48.9  (17)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
36
  73.5%
35
  68.6%
71
  71.0%
>=65 years
13
  26.5%
16
  31.4%
29
  29.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 100 participants
Female
22
  44.9%
23
  45.1%
45
  45.0%
Male
27
  55.1%
28
  54.9%
55
  55.0%
1.Primary Outcome
Title Number of New Nosocomial Infections After 48 Hrs of Parenteral Nutrition (PN) Between the 2 Groups During Their Hospital Stay
Hide Description New nosocomial infections, defined as culture-proven infection including wound, drain, bloodstream, respiratory tract, and urinary tract infections during PN. The presence of nosocomial infections was diagnosed based on standardized Centers for Disease Control (CDC) guidelines for laboratory-confirmed bloodstream infection and did not distinguish catheter-related infections per se. The following daily information was evaluated by the study team for nosocomial infection surveillance: temperature (fever)curve, white blood cell counts, review of daily progress notes in the medical record, daily clinical microbiology laboratory culture data, orders for antimicrobial agents (agent, daily dose, and start/stop times will be recorded), review of all relevant dictated radiographic reports (e.g., chest radiographs, abdominal computer tomography), communication, as needed, with primary physicians and site infectious disease consultants, and use of the CDC guidelines.
Time Frame 2 days after Parenteral Nutrition (up to 28 days post randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Hide Arm/Group Description:

Total Parenteral Nutrition (TPN) subjects receive Intralipid 20% (soybean-based)

Intralipid: TPN with Intralipid (20%)

Total Parenteral Nutrition (TPN) subjects receive ClinOleic 20% (olive oil based)

ClinOleic: TPN with ClinOleic (20%)

Overall Number of Participants Analyzed 49 51
Measure Type: Number
Unit of Measure: number of nosocomial infections
21 29
2.Secondary Outcome
Title Number of Days Patients Stayed in ICU During Parenteral Nutrition Between Treatment Groups
Hide Description The mean number of days patients stayed in the intensive care unit between the Intralipid 20% and ClinOleic 20% while they are on parenteral nutrition is calculated and compared
Time Frame During Parenteral Nutrition (up to 28 days post randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Hide Arm/Group Description:

TPN subjects receive Intralipid (soybean-based)

Intralipid: TPN with Intralipid (20%)

TPN subjects receive ClinOleic 20% (olive oil based)

ClinOleic: TPN with ClinOleic (20%)

Overall Number of Participants Analyzed 49 51
Mean (Standard Deviation)
Unit of Measure: days
15.2  (14) 17  (18)
3.Secondary Outcome
Title Mean Plasma Concentration of C-reactive Protein in mg/L at Baseline, Day 3 and Day 7 Among the Treatment Groups Will be Measured
Hide Description Peripheral blood samples will be analyzed for circulating levels of inflammatory markers markers like plasma C-reactive protein (CRP) at baseline, day 3, and day 7 of soybean oil– and olive oil–based parenteral nutrition infusion and compared. A reading of less than 1 mg/L indicates low risk; a reading between 1 and 2.9 mg/L indicates intermediate risk; a reading greater than 3 mg/L indicates high risk and a reading above 10 mg/L indicates a need for further testing. Since the patients are sick and hospitalized, it is expected that their levels are elevated compared to normal subjects. The levels between the 2 groups are compared to see if there is any difference.Levels were measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the Immulite analyzer.
Time Frame Baseline, Day 3 and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Hide Arm/Group Description:

TPN subjects receive Intralipid (soybean-based)

Intralipid: TPN with Intralipid (20%)

TPN subjects receive ClinOleic 20% (olive oil based)

ClinOleic: TPN with ClinOleic (20%)

Overall Number of Participants Analyzed 49 51
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline 169.67  (125.05) 152.45  (123.09)
Day 3 109.48  (58.42) 115.33  (66.80)
Day 7 122.71  (80.68) 146.63  (115)
4.Secondary Outcome
Title Mean Plasma Concentration of Tumor Necrosis Factor-alpha, in pg/mL is Measured Between the Two Treatment Groups
Hide Description Plasma concentration of circulating levels of inflammatory stress markers like tumor necrosis factor-alpha is measured at baseline, day 3, and day 7 among soybean oil– and olive oil–based parenteral nutrition infusion groups. The normal reference values are < or =2.8 pg/mL. Levels were measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the Immulite analyzer.
Time Frame Baseline, Day 3 and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Hide Arm/Group Description:

TPN subjects receive Intralipid (soybean-based)

Intralipid: TPN with Intralipid (20%)

TPN subjects receive ClinOleic 20% (olive oil based)

ClinOleic: TPN with ClinOleic (20%)

Overall Number of Participants Analyzed 49 51
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline 0.12  (0.08) 0.09  (0.03)
Day 3 0.12  (0.05) 0.09  (0.03)
Day 7 0.10  (0.04) 0.10  (0.07)
5.Secondary Outcome
Title Mean Change in Plasma Concentration of Cystine in Micromol Per Liter at Baseline, Day 3 and Day 7 Among the Treatment Groups
Hide Description Mean Plasma concentration of circulating levels of oxidative stress markers like levels of cystine at baseline, day 3, and day 7 are measured and compared between the soybean oil– and olive oil–based parenteral nutrition infusion groups. Levels were measured using iodoacetate to alkylate free thiols, derivatization with dansyl chloride to fluorescently tag amino groups, and high pressure liquid chromatography (HPLC) and fluorescence to separate, detect, and quantify the molecules.
Time Frame Baseline, Day 3 and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Hide Arm/Group Description:

TPN subjects receive Intralipid (soybean-based)

Intralipid: TPN with Intralipid (20%)

TPN subjects receive ClinOleic 20% (olive oil based)

ClinOleic: TPN with ClinOleic (20%)

Overall Number of Participants Analyzed 49 51
Mean (Standard Deviation)
Unit of Measure: micromol per liter
Baseline 82.22  (43.74) 75.8  (31.09)
Day 3 88.65  (39.09) 93.54  (36.04)
Day 7 90.06  (42.28) 87.7  (42.04)
6.Secondary Outcome
Title Mean Hospital Blood Glucose (mg/dL) in Diabetic Patients is Measured During Parenteral Nutrition Between the Two Treatment Groups
Hide Description Mean hospital blood glucose is measured as an indicator for insulin sensitivity. Capillary blood glucose was measured with a glucose meter at bedside during PN infusion. For this study normal blood glucose levels were indicated as 70-200 mg/dL, any blood glucose level < 70 mg/dL is regarded as hypoglycemia and above 200 mg/dL is regarded as hyperglycemia.
Time Frame During Parenteral Nutrition (up to 28 days post randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Hide Arm/Group Description:

TPN subjects receive Intralipid (soybean-based)

Intralipid: TPN with Intralipid (20%)

TPN subjects receive ClinOleic 20% (olive oil based)

ClinOleic: TPN with ClinOleic (20%)

Overall Number of Participants Analyzed 49 51
Mean (Standard Deviation)
Unit of Measure: mg/dL
128.4  (6) 125  (9)
7.Secondary Outcome
Title Number of Deaths During Parenteral Nutrition Treatment Between Two Treatment Groups During Hospitalization
Hide Description Mortality is defined as death occurring during admission, either during the time PN is received or after PN treatment is completed. Death during hospitalization rather than during PN treatment was chosen because many patients who undergo treatment with PN die or develop hospital complications within a period of several days after treatment cessation. The number of deaths between the two groups are compared.
Time Frame During Parenteral Nutrition (up to 28 days post randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Hide Arm/Group Description:

TPN subjects receive Intralipid (soybean-based)

Intralipid: TPN with Intralipid (20%)

TPN subjects receive ClinOleic 20% (olive oil based)

ClinOleic: TPN with ClinOleic (20%)

Overall Number of Participants Analyzed 49 51
Measure Type: Number
Unit of Measure: participants
5 4
8.Secondary Outcome
Title Mean Change in Percentage of Granulocyte Phagocytosis After 7-day Administration of Parenteral Nutrition Between the Two Treatment Groups
Hide Description Change in immune function is assessed by percentage of Granulocyte phagocytosis after 7-day administration of parenteral nutrition between the two treatment groups. The phagocytic and oxidative burst activity of monocytes and granulocytes in heparinized whole blood was assessed according to manufacturer’s instructions using specific reagent kits for this purpose at baseline and again at day 7. Briefly, granulocyte phagocytic activity was quantitated by incubation of whole blood with fluorescein isothiocyanate-labeled, opsonized Escherichia coli bacteria at 37°C with detection of fluorescence of internalized particles as a percentage of positive cells by flow cytometry.
Time Frame Baseline and 7 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Hide Arm/Group Description:

TPN subjects receive Intralipid (soybean-based)

Intralipid: TPN with Intralipid (20%)

TPN subjects receive ClinOleic 20% (olive oil based)

ClinOleic: TPN with ClinOleic (20%)

Overall Number of Participants Analyzed 49 51
Mean (Standard Deviation)
Unit of Measure: percentage of phagocytosis
3.86  (18.8) 6.36  (38.4)
Time Frame The adverse events were calculated up to 28 days post randomization and on parenteral nutrition between the two treatment groups
Adverse Event Reporting Description Since the subjects enrolled are already hospitalized patients in the Intensive care unit, main adverse events of interest were serious adverse events and deaths are captured for the study
 
Arm/Group Title Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Hide Arm/Group Description

TPN subjects receive Intralipid 20% (soybean-based)

Intralipid: TPN with Intralipid (20%)

TPN subjects receive ClinOleic 20% (olive oil based)

ClinOleic: TPN with ClinOleic (20%)

All-Cause Mortality
Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Affected / at Risk (%) Affected / at Risk (%)
Total   5/49 (10.20%)   4/51 (7.84%) 
Show Serious Adverse Events Hide Serious Adverse Events
Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Affected / at Risk (%) Affected / at Risk (%)
Total   33/49 (67.35%)   44/51 (86.27%) 
Blood and lymphatic system disorders     
Bacteremia   11/49 (22.45%)  11/51 (21.57%) 
Cardiac disorders     
Acute myocardial infarction,   0/49 (0.00%)  2/51 (3.92%) 
Congestive heart failure,   1/49 (2.04%)  2/51 (3.92%) 
Cardiac arrhythmia,   5/49 (10.20%)  6/51 (11.76%) 
Renal and urinary disorders     
Urinary tract infection,   7/49 (14.29%)  7/51 (13.73%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia   5/49 (10.20%)  7/51 (13.73%) 
Skin and subcutaneous tissue disorders     
Wound infection,   4/49 (8.16%)  11/51 (21.57%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total Parenteral Nutrition (TPN) Given Intralipid 20% Total Parenteral Nutrition (TPN) Given ClinOleic 20%
Affected / at Risk (%) Affected / at Risk (%)
Total   2/49 (4.08%)   3/51 (5.88%) 
Surgical and medical procedures     
Vein irritation   2/49 (4.08%)  3/51 (5.88%) 
Indicates events were collected by systematic assessment
Limitations of the study included the relatively small number of patients, the preponderance of surgical ICU subjects, and that the study was not powered to demonstrate differences in mortality between treatment groups.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Guillermo Umpierrez
Organization: Emory University
Phone: 404-778-1665
Responsible Party: Guillermo Umpierrez, MD, Emory University
ClinicalTrials.gov Identifier: NCT00672854     History of Changes
Other Study ID Numbers: IRB00007587
TPN ( Other Grant/Funding Number: Baxter Healthcare Corporation )
First Submitted: April 18, 2008
First Posted: May 6, 2008
Results First Submitted: July 2, 2014
Results First Posted: August 1, 2014
Last Update Posted: October 17, 2018