Early Enteral Nutrition in Severe Acute Pancreatitis

NCT ID: NCT02000323

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-08-31

Brief Summary

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to compare different time points for enteral nutrition in SAP patients

Detailed Description

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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

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Pancreatitis

Keywords

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pancreatitis enteral nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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early enteral nutrition

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.

Group Type ACTIVE_COMPARATOR

early enteral nutrition

Intervention Type OTHER

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 nutrition

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.

Group Type ACTIVE_COMPARATOR

modified early enteral nutrition

Intervention Type OTHER

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.

Interventions

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early enteral nutrition

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

Intervention Type OTHER

modified early enteral nutrition

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase
2. Onset of abdominal pain within \<=72h before admission
3. moderate severe or severe Acute Pancreatitis according to Atlanta criteria revisited in 2012 ffff

Exclusion Criteria

* 1\. Pregnancy 2.tumor 3. acute onset of chronic pancreatitis
4. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erzhen Chen

Prefessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiang en Mao, phd

Role: STUDY_DIRECTOR

Emergency intensive care unit of Ruijin Hospital

Wen xu, Master

Role: PRINCIPAL_INVESTIGATOR

doctor

Locations

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Ruijin

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhen Er chen, PHD

Role: CONTACT

Phone: 64370045

Email: [email protected]

qiang En mao

Role: CONTACT

Facility Contacts

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Zhen Er Chen, PHD

Role: primary

References

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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.

Reference Type RESULT
PMID: 22908969 (View on PubMed)

Other Identifiers

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RJpancreatitis02

Identifier Type: OTHER

Identifier Source: secondary_id

RJpancreatitis02

Identifier Type: -

Identifier Source: org_study_id