NCT01376817

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 20, 2011

Status Verified

February 1, 2009

Enrollment Period

3 years

First QC Date

June 16, 2011

Last Update Submit

June 17, 2011

Conditions

Severe Acute Pancreatitis

Keywords

Severe acute pancreatitistotal parenteral nutritionfat emulsionsomega 3 fatty acids

Outcome Measures

Primary Outcomes (1)

  • Inflammatory markers

    LTB4, TXB2, PG2, IL-6, alfa-TNF, C-reactive protein (CRP) Day 1 (before treatment), 5 and 10

    Day 10

Secondary Outcomes (2)

  • Evolution of the degree of severity of acute severe pancreatitis

    During the first 72 hours after admission

  • Complications of acute severe pancreatitis

    Day 10.

Study Arms (2)

Omega 3

EXPERIMENTAL
Drug: Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids

MCT / LCT

ACTIVE COMPARATOR
Drug: Fat emulsion with MCT and LCT

Interventions

Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acidsDRUG

40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10

Omega 3
Fat emulsion with MCT and LCTDRUG

40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10

MCT / LCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Treatment with steroids \> 0.25 mg/kg/day of prednisone or equivalent doses of corticosteroids: as pre-treatment and / or during admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

PancreatitisHyperphagia

Interventions

soybean oil, phospholipid emulsionOlive OilFatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesFatty Acids, UnsaturatedFatty AcidsFish Oils

Study Officials

  • Daniel Cardona Pera, Doctor

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Virgili Arumí

CONTACT

00-34-932919050jvirgili@santpau.cat

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

July 1, 2008

Primary Completion

July 1, 2011

Study Completion

December 1, 2011

Last Updated

June 20, 2011

Record last verified: 2009-02

Locations

ES(1)