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

June 16, 2011
June 17, 2011
July 2008
July 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01376817 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Comparative Study About the Impact of Two Oil Emulsions Administered Intravenously on Severe Acute Pancreatitis
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

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.

Information recorded in other data elements.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Severe Acute Pancreatitis
  • 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
  • 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
  • Experimental: Omega 3
    Intervention: Drug: Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids
  • Active Comparator: MCT / LCT
    Intervention: Drug: Fat emulsion with MCT and LCT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jordi Virgili Arumí 00-34-932919050 ext 9303 jvirgili@santpau.cat
Spain
 
NCT01376817
ELomega3, 2007-005611-26
No
Dr. Daniel Cardona Pera (principal investigator), Section of Artificial Nutrition and Intravenous Mixtures, Fharmacy Service, Hospital de la Santa Creu i Sant Pau
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Not Provided
Principal Investigator: Daniel Cardona Pera, Doctor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP