Acute PancreatitisPhase 4NCT01965873
Enteral Nutrition in Acute Pancreatitis
A Phase 4 study testing Enteral nutrition in people with Acute Pancreatitis, run by University Hospital Rijeka.
Trial summary
The purpose of this prospective randomised clinical trial is to compare beneficial and harmful effects of the use enteral nutrition versus a nil-by-mouth and intravenous fluid replacement principle of treatment in patients with moderate to severe acute pancreatitis (AP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Enteral nutrition
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Jun 2012
- 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
- onset of symptoms consistent with AP within 72 hours before admission to the hospital
- an 3-fold elevation of serum amylase or serum lipase over the upper limit of normal
- APACHE II score 6 or more
- a signed informed consent
Who cannot join
- patients < 18 years of age
- pregnant and breastfeeding women
About this study
Official title: Enteral Nutrition for Treatment of Acute Pancreatitis - a Prospective, Randomized Clinical Trial
The purpose of this prospective randomised clinical trial is to compare beneficial and harmful effects of the use enteral nutrition versus a nil-by-mouth and intravenous fluid replacement principle of treatment in patients with moderate to severe acute pancreatitis (AP).
The hypothesis:
- enteral nutrition is no significantly better compared with the nil-by-mouth principle regarding mortality, incidence of local and systemic complications, length of hospital stay, and intensity of the inflammatory response in patients with moderate to severe AP
- enteral nutrition has the same safety as nil-by-mouth principle in patients with moderate to severe AP
Read the detailed description
Patients with first attack of AP irrespective of etiology will be enrolled in the study, if they are eligible according to the following criteria:
Inclusion criteria:
- onset of symptoms consistent with AP within 72 hours before admission to the hospital
- an 3-fold elevation of serum amylase or serum lipase over the upper limit of normal
- APACHE II score 6 or more
- a signed informed consent
Exclusion criteria:
- patients < 18 years of age
- pregnant and breastfeeding women
- Conditions
- Acute Pancreatitis
- Being tested
- Enteral nutrition
- Keywords
- Pancreatitis, Acute necrotizing, Enteral nutrition, Fasting, Complications, Mortality
- Medical subject headings
- Pancreatitis, Pancreatitis, Acute Necrotizing, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral nutritionDietary supplement
Same as arm description
| Study group | Role | What they receive |
|---|---|---|
| Enteral nutrition | Experimental | In the enteral nutrition group a nasojejunal feeding tube will be placed via esophagogastroduodenoscopy and the position confirmed radiographically. Nutritional support will be started within 24 hours of enrollment, supplying daily 105 kJ (25 kcal)/kg, and 1.5 g/kg of protein based on ideal body weight. An elemental product for enteral nutrition will be infused at a rate of 25 ml/h, and increased by 10 ml/h every 6 hours, until the target rate of 100 ml/h will be achieved within 24-48 hours. Receives: Dietary Supplement: Enteral nutrition |
| Nil-by-mouth treatment | No intervention | The nil-by-mouth treatment consists intravenous fluid replacement according to assessed needs via peripheral veins. This will include crystalloid (0.9% saline and 5% glucose), and colloid (10% hydroxyethyl starch and 3.5% plasma expander - haemaccel) solutions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIRS (Systemic Inflammatory Response Syndrome)
Measured: 4 weeks
Secondary outcomes (8)
All-cause mortality
Measured: 4 weeks
Organ failure (cardiovascular, respiratory, renal)
Measured: 4 weeks
Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess)
Measured: 4 weeks
Local septic complications
Measured: 4 weeks
Other infections
Measured: 4 weeks
Inflammatory response (CRP on the first and third day)
Measured: First and third day of admission
Length of hospital stay
Measured: 4 weeks
Adverse events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startMay 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goran Poropat, University Hospital Rijeka
- Investigators
- Davor Štimac, MD, PhD, Principal investigator, Department of Gastroenterology, University Hospital Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965873
- Sponsor's protocol ID
- 062-0000000-0211
- Status last verified
- Mar 2015
- First submitted
- 16 Oct 2013
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stimac D, Poropat G, Hauser G, Licul V, Franjic N, Valkovic Zujic P, Milic S. Early nasojejunal tube feeding versus nil-by-mouth in acute pancreatitis: A randomized clinical trial. Pancreatology. 2016 Jul-Aug;16(4):523-8. doi: 10.1016/j.pan.2016.04.003. Epub 2016 Apr 13.
PubMed 27107634
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Nutrition for Treatment of Acute Pancreatitis - a Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01965873
- Acronym / sponsor ID
- 062-0000000-0211
- Conditions
- Acute Pancreatitis
- Keywords
- Pancreatitis, Acute necrotizing, Enteral nutrition, Fasting, Complications, Mortality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University Hospital RijekaUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Oct 2013 (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 prospective randomised clinical trial is to compare beneficial and harmful effects of the use enteral nutrition versus a nil-by-mouth and intravenous fluid replacement principle of treatment in patients with moderate to severe acute pancreatitis (AP).
The hypothesis:
- enteral nutrition is no significantly better compared with the nil-by-mouth principle regarding mortality, incidence of local and systemic complications, length of hospital stay, and intensity of the inflammatory response in patients with moderate to severe AP
- enteral nutrition has the same safety as nil-by-mouth principle in patients with moderate to severe AP
Detailed description
Patients with first attack of AP irrespective of etiology will be enrolled in the study, if they are eligible according to the following criteria:
Inclusion criteria:
- onset of symptoms consistent with AP within 72 hours before admission to the hospital
- an 3-fold elevation of serum amylase or serum lipase over the upper limit of normal
- APACHE II score 6 or more
- a signed informed consent
Exclusion criteria:
- patients < 18 years of age
- pregnant and breastfeeding women
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral nutrition | Experimental | Dietary Supplement: Enteral nutritionIn the enteral nutrition group a nasojejunal feeding tube will be placed via esophagogastroduodenoscopy and the position confirmed radiographically. Nutritional support will be started within 24 hours of enrollment, supplying daily 105 kJ (25 kcal)/kg, and 1.5 g/kg of protein based on ideal body weight. An elemental product for enteral nutrition will be infused at a rate of 25 ml/h, and increased by 10 ml/h every 6 hours, until the target rate of 100 ml/h will be achieved within 24-48 hours. |
| Nil-by-mouth treatment | No intervention | –The nil-by-mouth treatment consists intravenous fluid replacement according to assessed needs via peripheral veins. This will include crystalloid (0.9% saline and 5% glucose), and colloid (10% hydroxyethyl starch and 3.5% plasma expander - haemaccel) solutions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- onset of symptoms consistent with AP within 72 hours before admission to the hospital
- an 3-fold elevation of serum amylase or serum lipase over the upper limit of normal
- APACHE II score 6 or more
- a signed informed consent
Key exclusion criteria (2 listed)
- patients < 18 years of age
- pregnant and breastfeeding women
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 |
|---|---|---|
| Enteral nutritionSame as arm description | Dietary supplement | Enteral nutrition |
Primary outcome
SIRS (Systemic Inflammatory Response Syndrome)
Time frame: 4 weeks
8 secondary outcomes
All-cause mortality
Time frame: 4 weeks
Organ failure (cardiovascular, respiratory, renal)
Time frame: 4 weeks
Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess)
Time frame: 4 weeks
Local septic complications
Time frame: 4 weeks
Other infections
Time frame: 4 weeks
Inflammatory response (CRP on the first and third day)
Time frame: First and third day of admission
Length of hospital stay
Time frame: 4 weeks
Adverse events
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Derived from this study: PubMed 27107634Stimac D, Poropat G, Hauser G, Licul V, Franjic N, Valkovic Zujic P, Milic S. Early nasojejunal tube feeding versus nil-by-mouth in acute pancreatitis: A randomized clinical trial. Pancreatology. 2016 Jul-Aug;16(4):523-8. doi: 10.1016/j.pan.2016.04.003. Epub 2016 Apr 13.
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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.
Davor Štimac, MD, PhD principal investigator
Department of Gastroenterology, University Hospital Rijeka
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enteral nutrition in people with Acute Pancreatitis, run by University Hospital Rijeka.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIRS (Systemic Inflammatory Response Syndrome) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01965873, which also lists 1 linked publication.
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 3 Apr 2015.