Severe Acute Pancreatitis
Conditions
Keywords
Severe acute pancreatitis, total parenteral nutrition, fat emulsions, omega 3 fatty acids
Brief summary
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.
Detailed description
Information recorded in other data elements.
Interventions
DRUGFat emulsion with MCT, LCT, olive oil and omega 3 fatty acids
40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10
DRUGFat emulsion with MCT and LCT
40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of acute pancreatitis: characteristic abdominal pain, serum amylase and / or lipase \>= 3 times the upper limit of normal range, characteristic CT-scan * Criteria of severity of acute pancreatitis diagnosed at \<= 72 hours following admission: severity Index of Balthazar's CT-scan (with contrast) \>= grade D, APACHE-II \>= 8, C-reactive protein \>= 150 mg/L * Inability to initiate feeding (oral or with nutritional supplements) and / or enteral nutrition during the 5 days after the diagnosis and prediction of the indication of nil-by-mouth \>= 5 days * \<= 3 mmol/L of triglycerides in the blood * Men and women aged \>= 18 years old * Acceptance of informed consent
Exclusion criteria
* Known hipersensitivity to the fish, egg or soy proteins * Lipid etiology * \> 3 mmol/L of triglycerides in the blood * Severe hepatic impairment * Severe renal insufficiency without dialysis or haemofiltration * Serious disturbances of blood clotting * Acute shock * Infusion therapy general contraindications * Clinical conditions of instability that must not be taken with parenteral nutrition * Have other acute or chronic inflammatory diseases * Status of severe immunosuppression: cytotoxic treatment in 15 days prior to inclusion and / or a disease that causes white blood cells levels \<5000/mm3 * Treatment with steroids \> 0.25 mg/kg/day of prednisone or equivalent doses of corticosteroids: as pre-treatment and / or during admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory markers | Day 10 | LTB4, TXB2, PG2, IL-6, alfa-TNF, C-reactive protein (CRP) Day 1 (before treatment), 5 and 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the degree of severity of acute severe pancreatitis | During the first 72 hours after admission | 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. |
| Complications of acute severe pancreatitis | Day 10. | 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). |
Countries
Spain
Contacts
Primary ContactJordi Virgili Arumí
Outcome results
None listed