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| ID | Type | Description | Link |
|---|---|---|---|
| TPN | Other Grant/Funding Number | Baxter Healthcare Corporation |
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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralipid 20% Intravenous Emulsion | Active Comparator | Subjects who require Total Parenteral Nutrition TPN receiving Intralipid 20% (soybean-based) |
|
| ClinOleic 20% Intravenous Emulsion | Experimental | Subjects who require Total Parenteral Nutrition TPN receiving ClinOleic 20% (olive oil based) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClinOleic 20% Intravenous Emulsion | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of New Nosocomial Infections After 48 Hrs of Parenteral Nutrition (PN) Between the 2 Groups During Their Hospital Stay | 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. | 2 days after Parenteral Nutrition (up to 28 days post randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Patients Stayed in ICU During Parenteral Nutrition Between Treatment Groups | 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 | During Parenteral Nutrition (up to 28 days post randomization) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Umpierrez, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22488002 | Result | 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. |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Parenteral Nutrition (TPN) Given Intralipid 20% | TPN subjects receive Intralipid (soybean-based) Intralipid: TPN with Intralipid (20%) |
| FG001 | Total Parenteral Nutrition (TPN) Given ClinOleic 20% | TPN subjects receive ClinOleic 20% (olive oil based) ClinOleic: TPN with ClinOleic (20%) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Parenteral Nutrition (TPN) Given Intralipid 20% | TPN subjects receive Intralipid (soybean-based) Intralipid: TPN with Intralipid (20%) |
| BG001 | Total Parenteral Nutrition (TPN) Given ClinOleic 20% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of New Nosocomial Infections After 48 Hrs of Parenteral Nutrition (PN) Between the 2 Groups During Their Hospital Stay | 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. | Posted | Number | number of nosocomial infections | 2 days after Parenteral Nutrition (up to 28 days post randomization) |
|
The adverse events were calculated up to 28 days post randomization and on parenteral nutrition between the two treatment groups
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Parenteral Nutrition (TPN) Given Intralipid 20% | TPN subjects receive Intralipid 20% (soybean-based) Intralipid: TPN with Intralipid (20%) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vein irritation | Surgical and medical procedures | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Umpierrez | Emory University | 404-778-1665 | geumpie@emory.edu |
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| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D003428 | Cross Infection |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C568346 | ClinOleic |
| D005217 | Fat Emulsions, Intravenous |
| C545823 | soybean oil, phospholipid emulsion |
| ID | Term |
|---|---|
| D004655 | Emulsions |
| D003102 | Colloids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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|
|
| Intralipid, 20% Intravenous Emulsion | Drug | It is made up of 20% Soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection |
|
|
| Mean Plasma Concentration of C-reactive Protein in mg/L at Baseline, Day 3 and Day 7 Among the Treatment Groups Will be Measured |
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. |
| Baseline, Day 3 and Day 7 |
| Mean Plasma Concentration of Tumor Necrosis Factor-alpha, in pg/mL is Measured Between the Two Treatment Groups | 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. | Baseline, Day 3 and Day 7 |
| Mean Change in Plasma Concentration of Cystine in Micromol Per Liter at Baseline, Day 3 and Day 7 Among the Treatment Groups | 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. | Baseline, Day 3 and Day 7 |
| Mean Hospital Blood Glucose (mg/dL) in Diabetic Patients is Measured During Parenteral Nutrition Between the Two Treatment Groups | 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. | During Parenteral Nutrition (up to 28 days post randomization) |
| Number of Deaths During Parenteral Nutrition Treatment Between Two Treatment Groups During Hospitalization | 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. | During Parenteral Nutrition (up to 28 days post randomization) |
| Mean Change in Percentage of Granulocyte Phagocytosis After 7-day Administration of Parenteral Nutrition Between the Two Treatment Groups | 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. | Baseline and 7 days post randomization |
| Atlanta |
| Georgia |
| 30322 |
| United States |
TPN subjects receive ClinOleic 20% (olive oil based)
ClinOleic: TPN with ClinOleic (20%)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Total Parenteral Nutrition (TPN) Given Intralipid 20% | Total Parenteral Nutrition (TPN) subjects receive Intralipid 20% (soybean-based) Intralipid: TPN with Intralipid (20%) |
| OG001 | Total Parenteral Nutrition (TPN) Given ClinOleic 20% | Total Parenteral Nutrition (TPN) subjects receive ClinOleic 20% (olive oil based) ClinOleic: TPN with ClinOleic (20%) |
|
|
| Secondary | Number of Days Patients Stayed in ICU During Parenteral Nutrition Between Treatment Groups | 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 | Posted | Mean | Standard Deviation | days | During Parenteral Nutrition (up to 28 days post randomization) |
|
|
|
| Secondary | Mean Plasma Concentration of C-reactive Protein in mg/L at Baseline, Day 3 and Day 7 Among the Treatment Groups Will be Measured | 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. | Posted | Mean | Standard Deviation | mg/L | Baseline, Day 3 and Day 7 |
|
|
|
| Secondary | Mean Plasma Concentration of Tumor Necrosis Factor-alpha, in pg/mL is Measured Between the Two Treatment Groups | 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. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Day 3 and Day 7 |
|
|
|
| Secondary | Mean Change in Plasma Concentration of Cystine in Micromol Per Liter at Baseline, Day 3 and Day 7 Among the Treatment Groups | 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. | Posted | Mean | Standard Deviation | micromol per liter | Baseline, Day 3 and Day 7 |
|
|
|
| Secondary | Mean Hospital Blood Glucose (mg/dL) in Diabetic Patients is Measured During Parenteral Nutrition Between the Two Treatment Groups | 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. | Posted | Mean | Standard Deviation | mg/dL | During Parenteral Nutrition (up to 28 days post randomization) |
|
|
|
| Secondary | Number of Deaths During Parenteral Nutrition Treatment Between Two Treatment Groups During Hospitalization | 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. | Posted | Number | participants | During Parenteral Nutrition (up to 28 days post randomization) |
|
|
|
| Secondary | Mean Change in Percentage of Granulocyte Phagocytosis After 7-day Administration of Parenteral Nutrition Between the Two Treatment Groups | 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. | Posted | Mean | Standard Deviation | percentage of phagocytosis | Baseline and 7 days post randomization |
|
|
|
| 5 |
| 49 |
| 33 |
| 49 |
| 2 |
| 49 |
| EG001 | Total Parenteral Nutrition (TPN) Given ClinOleic 20% | TPN subjects receive ClinOleic 20% (olive oil based) ClinOleic: TPN with ClinOleic (20%) | 4 | 51 | 44 | 51 | 3 | 51 |
| Urinary tract infection, | Renal and urinary disorders | Systematic Assessment |
|
| Bacteremia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Wound infection, | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Acute myocardial infarction, | Cardiac disorders | Systematic Assessment |
|
| Congestive heart failure, | Cardiac disorders | Systematic Assessment |
|
| Cardiac arrhythmia, | Cardiac disorders | Systematic Assessment |
|
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| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D057947 |
| Parenteral Nutrition Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| Day 7 |
|
| Day 7 |
|
| Day 7 |
|