Severe Acute PancreatitisPhase 4NCT01376817
Comparative Study About the Impact of Two Oil Emulsions Administered Intravenously on Severe Acute Pancreatitis
A Phase 4 study testing Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids and Fat emulsion with MCT and LCT in people with Severe Acute Pancreatitis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Pancreatitis
- What is being tested?
- Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids and Fat emulsion with MCT and LCT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2008to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Jordi Virgili Arumí, 00-34-932919050 ext. 9303, jvirgili@santpau.cat
Daniel Cardona Pera, Doctor
About this study
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
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.
Read the detailed description
Information recorded in other data elements.
- Conditions
- Severe Acute Pancreatitis
- Being tested
- Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids, Fat emulsion with MCT and LCT
- Keywords
- Severe acute pancreatitis, total parenteral nutrition, fat emulsions, omega 3 fatty acids
- Medical subject headings
- Pancreatitis, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 | Experimental | Not described Receives: Drug: Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids |
| MCT / LCT | Active comparator | Not described Receives: Drug: Fat emulsion with MCT and LCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers
LTB4, TXB2, PG2, IL-6, alfa-TNF, C-reactive protein (CRP) Day 1 (before treatment), 5 and 10
Measured: Day 10
Secondary outcomes (2)
Evolution of the degree of severity of acute severe pancreatitis
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.
Measured: During the first 72 hours after admission
Complications of acute severe pancreatitis
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).
Measured: Day 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJul 2008
- Primary completionJul 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Cardona Pera, Doctor, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376817
- Sponsor's protocol ID
- ELomega3
- Other IDs
- 2007-005611-26
- Status last verified
- Feb 2009
- First submitted
- 16 Jun 2011
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01376817
- Acronym / sponsor ID
- ELomega3
- Conditions
- Severe Acute Pancreatitis
- Keywords
- Severe acute pancreatitis, total parenteral nutrition, fat emulsions, omega 3 fatty acids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Information recorded in other data elements.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10 | Drug | Omega 3 |
| Fat emulsion with MCT and LCT40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10 | Drug | MCT / LCT |
Primary outcome
Inflammatory markers
Time frame: Day 10
LTB4, TXB2, PG2, IL-6, alfa-TNF, C-reactive protein (CRP) Day 1 (before treatment), 5 and 10
2 secondary outcomes
Evolution of the degree of severity of acute severe pancreatitis
Time frame: During the first 72 hours after admission
Complications of acute severe pancreatitis
Time frame: Day 10.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2011.
- Hospital de la Santa Creu i Sant Pau's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Cardona Pera, Doctor principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids and Fat emulsion with MCT and LCT in people with Severe Acute Pancreatitis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordi Virgili Arumí (00-34-932919050 ext. 9303, jvirgili@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory markers (time frame: Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2011.