Comparative Study About the Impact of Two Oil Emulsions Administered Intravenously on Severe Acute Pancreatitis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01376817
First received: June 16, 2011
Last updated: June 17, 2011
Last verified: February 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Severe Acute Pancreatitis |
Drug: Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids Drug: Fat emulsion with MCT and LCT |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) |
| Official Title: | Comparative Study About the Impact of Two Oil Emulsions, One of Them Formulated With MCT, LCT, Olive Oil and Omega 3 Fatty Acids Versus Another One Formulated With MCT and LCT, Administered Intravenously on Severe Acute Pancreatitis Clinical Evolution |
Resource links provided by NLM:
Genetics Home Reference related topics:
hereditary pancreatitis
MedlinePlus related topics:
Pancreatitis
U.S. FDA Resources
Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Primary Outcome Measures:
- Inflammatory markers [ Time Frame: Day 10 ] [ Designated as safety issue: No ]LTB4, TXB2, PG2, IL-6, alfa-TNF, C-reactive protein (CRP) Day 1 (before treatment), 5 and 10
Secondary Outcome Measures:
- Evolution of the degree of severity of acute severe pancreatitis [ Time Frame: During the first 72 hours after admission ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 10. ] [ Designated as safety issue: No ]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).
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Omega 3 |
Drug: Fat 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
|
| Active Comparator: MCT / LCT |
Drug: Fat 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
|
Detailed Description:
Information recorded in other data elements.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376817
Contacts
| Contact: Jordi Virgili Arumí | 00-34-932919050 ext 9303 | jvirgili@santpau.cat |
Locations
| Spain | |
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Contact: Jordi Virgili Arumí 00-34-932919050 ext 9303 jvirgili@santpau.cat | |
| Principal Investigator: Daniel Cardona Pera, Doctor | |
| Sub-Investigator: Amelia Romero Merlos, Bachelor | |
| Sub-Investigator: Juan María Sánchez Segura, Doctor | |
| Sub-Investigator: Ferran Caballero Mestres, Doctor | |
| Sub-Investigator: Manuel Rodríguez Blanco, Doctor | |
| Sub-Investigator: Vicens Artigas Raventós, Doctor | |
| Sub-Investigator: Josefina Muñoz Casadevall, Doctor | |
| Sub-Investigator: Maria Antònia Mangues Bafalluy, Doctor | |
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
| Principal Investigator: | Daniel Cardona Pera, Doctor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Daniel Cardona Pera (principal investigator), Section of Artificial Nutrition and Intravenous Mixtures, Fharmacy Service, Hospital de la Santa Creu i Sant Pau |
| ClinicalTrials.gov Identifier: | NCT01376817 History of Changes |
| Other Study ID Numbers: | ELomega3, 2007-005611-26 |
| Study First Received: | June 16, 2011 |
| Last Updated: | June 17, 2011 |
| Health Authority: | Spain: Ministry of Health and Consumption |
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
|
Severe acute pancreatitis total parenteral nutrition fat emulsions omega 3 fatty acids |
Additional relevant MeSH terms:
|
Pancreatitis Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013