PancreatitisNCT02000323
Early Enteral Nutrition in Severe Acute Pancreatitis
A study testing early enteral nutrition and modified early enteral nutrition in people with Pancreatitis, run by Ruijin Hospital at 1 site in China.
Trial summary
to compare different time points for enteral nutrition in SAP patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatitis
- What is being tested?
- early enteral nutrition and modified early enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Aug 2017
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase
- Onset of abdominal pain within <=72h before admission
- moderate severe or severe Acute Pancreatitis according to Atlanta criteria revisited in 2012 ffff
Who cannot join
- 1. Pregnancy 2.tumor 3. acute onset of chronic pancreatitis
- chronic disease of any organ （heart lung gastrointestinal renal etc.） 5. Pre-existing disease with life expectancy < 3 months 7.receive parenteral nutrition or enteral nutrition before admitting
Trial locations and contacts
1 site in 1 country.
qiang En mao contact
China1 site, 1 recruiting
- Recruiting
Ruijin
Shanghai, Shanghai Municipality
Zhen Er Chen, PHD, 64370045 ext. 665590, elmaxuwen@gmail.com
xu Wen
About this study
to compare different time points for enteral nutrition in SAP patients
Read the detailed description
There is increasing evidence that indicates Early Enteral Nutrition（EEN） may be associated with improved outcome in acute pancreatitis patients. However, some SAP patients failed to EEN. The researchers of this study aim to investigate the opportunity of EEN on the clinical outcomes of SAP patients.
- Conditions
- Pancreatitis
- Being tested
- early enteral nutrition, modified early enteral nutrition
- Keywords
- pancreatitis, enteral nutrition
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early enteral nutritionOther
Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission.
The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray.
- After catharsis, Standard enteral nutrition liquid regimen will be used step by step.
Patients are targeted to receive calories for 25 kcal/kg/day.
nutrition form: short peptide ,1 kcal/ml,target 200k kcal/day
modified early enteral nutritionOther
Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission.
- The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray.
- After catharsis, Only Normal Saline were given through nasojejunal tube until 2 or more followed requirements were meted (mean arterial pressure≥65mmHg; oxygenation index≥ 300;APCHEII≤8; intra-abdominal pressure <20mmHg).Then Standard enteral nutrition liquid regimen (Peptisorb Liquid) will be used step by step.
- Patients are targeted to receive calories for 25 kcal/kg/day.
| Study group | Role | What they receive |
|---|---|---|
| early enteral nutrition | Active comparator | Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission.
* The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray.
* After catharsis, Standard enteral nutrition liquid regimen （Peptisorb Liquid）will be used step by step.
* Patients are targeted to receive calories for 25 kcal/kg/day. Receives: Other: early enteral nutrition |
| modified early enteral nutrition | Active comparator | Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission.
* The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray.
* After catharsis, Only Normal Saline were given through Naso-gastro-Jejunal tube until 2 or more followed requirements were met mean arterial pressure≥65mmHg; oxygenation index≥ 300;APCHEII≤8; intra-abdominal pressure <20mmHg).Then Standard enteral nutrition liquid regimen (Peptisorb Liquid) will be used step by step.
* Patients are targeted to receive calories for 25 kcal/kg/day. Receives: Other: modified early enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
the rate of patients died
Measured: 28days
Secondary outcomes (2)
operation rate
The rate of patients received operation for pancreatitis debridement
Measured: 2 months
fulfilling enteral nutrition target（≥25Kcal/kg/day）
enteral nutrition target set as ≥25Kcal/kg/day
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startAug 2012
- Primary completionSep 2016 (estimated)
- Study completionAug 2017 (estimated)
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 PancreatitisStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital
- Responsible party
- Principal investigator, Erzhen Chen, Ruijin Hospital
- Investigators
- Qiang en Mao, phd, Study director, Emergency intensive care unit of Ruijin HospitalWen xu, Master, Principal investigator, doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000323
- Sponsor's protocol ID
- RJpancreatitis02
- Other IDs
- RJpancreatitis02
- Status last verified
- Nov 2013
- First submitted
- 5 Nov 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ong JP, Fock KM. Nutritional support in acute pancreatitis. J Dig Dis. 2012 Sep;13(9):445-52. doi: 10.1111/j.1751-2980.2012.00611.x.
PubMed 22908969
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Enteral Nutrition in Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT02000323
- Acronym / sponsor ID
- RJpancreatitis02
- Conditions
- Pancreatitis
- Keywords
- pancreatitis, enteral nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital
- Study start
- Aug 2012
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 4 Dec 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.
to compare different time points for enteral nutrition in SAP patients
Detailed description
There is increasing evidence that indicates Early Enteral Nutrition（EEN） may be associated with improved outcome in acute pancreatitis patients. However, some SAP patients failed to EEN. The researchers of this study aim to investigate the opportunity of EEN on the clinical outcomes of SAP patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early enteral nutrition | Active comparator | Other: early enteral nutritionNaso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. * The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. * After catharsis, Standard enteral nutrition liquid regimen （Peptisorb Liquid）will be used step by step. * Patients are targeted to receive calories for 25 kcal/kg/day. |
| modified early enteral nutrition | Active comparator | Other: modified early enteral nutritionNaso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. * The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. * After catharsis, Only Normal Saline were given through Naso-gastro-Jejunal tube until 2 or more followed requirements were met mean arterial pressure≥65mmHg; oxygenation index≥ 300;APCHEII≤8; intra-abdominal pressure <20mmHg).Then Standard enteral nutrition liquid regimen (Peptisorb Liquid) will be used step by step. * Patients are targeted to receive calories for 25 kcal/kg/day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase
- Onset of abdominal pain within <=72h before admission
- moderate severe or severe Acute Pancreatitis according to Atlanta criteria revisited in 2012 ffff
Key exclusion criteria (2 listed)
- chronic disease of any organ （heart lung gastrointestinal renal etc.） 5. Pre-existing disease with life expectancy < 3 months 7.receive parenteral nutrition or enteral nutrition before admitting
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 |
|---|---|---|
| early enteral nutritionNaso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. • After catharsis, Standard enteral nutrition liquid regimen will be used step by step. Patients are targeted to receive calories for 25 kcal/kg/day. nutrition form: short peptide ,1 kcal/ml,target 200k kcal/day | Other | early enteral nutrition |
| modified early enteral nutritionNaso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. * The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. * After catharsis, Only Normal Saline were given through nasojejunal tube until 2 or more followed requirements were meted (mean arterial pressure≥65mmHg; oxygenation index≥ 300;APCHEII≤8; intra-abdominal pressure <20mmHg).Then Standard enteral nutrition liquid regimen (Peptisorb Liquid) will be used step by step. * Patients are targeted to receive calories for 25 kcal/kg/day. | Other | modified early enteral nutrition |
Primary outcome
mortality
Time frame: 28days
the rate of patients died
2 secondary outcomes
operation rate
Time frame: 2 months
fulfilling enteral nutrition target（≥25Kcal/kg/day）
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Results publication: PubMed 22908969Ong JP, Fock KM. Nutritional support in acute pancreatitis. J Dig Dis. 2012 Sep;13(9):445-52. doi: 10.1111/j.1751-2980.2012.00611.x.
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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.
qiang En mao contact
Qiang en Mao, phd study director
Emergency intensive care unit of Ruijin Hospital
Wen xu, Master principal investigator
doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early enteral nutrition and modified early enteral nutrition in people with Pancreatitis, run by Ruijin Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 4 Dec 2013. 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 China. 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.
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 Zhen Er chen, PHD (64370045 ext. 665520, chenerzhen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 28days). 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 NCT02000323, 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 4 Dec 2013.