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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005611-26 |
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The purpose of this study is to comparatively assess the potential antiinflammatory effects of intravenous lipid emulsions rich in omega 3 polyunsaturated fatty acids and olive oil versus intravenous lipid emulsions made exclusively with MCT and LCT on the evolution of patients with severe acute pancreatitis during the period in needing artificial nutrition support with total parenteral nutrition so unique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega 3 | Experimental |
| |
| MCT / LCT | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids | Drug | 40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers | LTB4, TXB2, PG2, IL-6, alfa-TNF, C-reactive protein (CRP) Day 1 (before treatment), 5 and 10 | Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the degree of severity of acute severe pancreatitis | At hospital admission: age, BMI, organ failure. Evolution of the degree of severity of acute severe pancreatitis: severity risk factors at the hospital admission (age, BMI, organ failure), pronostic signs of severity during the first 72 hours after admission : APACHE-II, Ranson criteria, serum hematocrit, CT-scan with Balthazar index, CRP. Day 10: CT-scan with Balthazar index, CRP. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordi Virgili Arumí | Contact | 00-34-932919050 | 9303 | jvirgili@santpau.cat |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Cardona Pera, Doctor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Barcelona | 08025 | Spain |
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| Label | URL |
|---|---|
| Hospital de la Santa Creu i Sant Pau's website | View source |
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| Fat emulsion with MCT and LCT | Drug | 40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10 |
|
| During the first 72 hours after admission |
| Complications of acute severe pancreatitis | From day 1 to day 10. Complications of acute severe pancreatitis: local complications (necrosis, pseudocyst, abscess, surgery, ERCP), systemic complications (SIRS, sepsis, organ failure, other ones, mortality). | Day 10. |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
| D000069463 | Olive Oil |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
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