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Redesign of study protocol.
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Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US. Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be associated with a number of complications including inflammation, abnormal liver function tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of intolerance to soybean oil IVFE. This study is designed to investigate the impact of SMOFlipid in prolonged use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMOFLipid | Experimental | Patients in this arm with be randomized to SMOFlipid as their lipid emulsion |
|
| Standard therapy | Active Comparator | Patients in this arm will be continue with their current lipid emulsion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMOFLipid | Drug | SMOFlipid is a lipid emulsion formed using soybean oil, medium chain triglycerides, olive oil, and fish oil. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AST | Primary aim is to assess impact on AST (liver enzyme) | 3-12 months |
| Glucose | blood glucose | 3-12 months |
| Triglycerides | blood triglycerides | 3-12 months |
| ALT | liver enzyme | 3-12 months |
| Total bilirubin | Liver study | 3-12 months |
| CRP | inflammatory marker | 3-12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manpreet S Mundi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000709826 | SMOFlipid |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard therapy | Drug | In most cases standard therapy will be IntraLipid. |
|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |