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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
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014