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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01376817 |
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Date of registration:
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16/06/2011 |
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Primary sponsor: |
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Public title:
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Comparative Study About the Impact of Two Oil Emulsions Administered Intravenously on Severe Acute Pancreatitis
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Scientific title:
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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 |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01376817 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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Countries of recruitment
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Spain
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Contacts
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Name:
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Jordi Virgili Arumí |
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Address:
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Telephone:
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00-34-932919050 |
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Email:
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jvirgili@santpau.cat |
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Affiliation:
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Name:
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Jordi Virgili Arumí |
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Address:
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Telephone:
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00-34-932919050 |
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Email:
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jvirgili@santpau.cat |
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Affiliation:
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Name:
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Daniel Cardona Pera, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Severe Acute Pancreatitis
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Intervention(s)
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Drug: Fat emulsion with MCT and LCT
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Drug: Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids
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Primary Outcome(s)
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Inflammatory markers
[Time Frame: Day 10]
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Secondary Outcome(s)
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Complications of acute severe pancreatitis
[Time Frame: Day 10.]
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Evolution of the degree of severity of acute severe pancreatitis
[Time Frame: During the first 72 hours after admission]
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Secondary ID(s)
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2007-005611-26
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ELomega3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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