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Early Enteral Nutrition in Severe Acute Pancreatitis

Primary Purpose

Pancreatitis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
early enteral nutrition
modified early enteral nutrition
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatitis focused on measuring pancreatitis, enteral nutrition

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RuijinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

early enteral nutrition

modified early enteral nutrition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

mortality
the rate of patients died

Secondary Outcome Measures

operation rate
The rate of patients received operation for pancreatitis debridement
fulfilling enteral nutrition target（≥25Kcal/kg/day）
enteral nutrition target set as ≥25Kcal/kg/day

Full Information

First Posted
November 5, 2013
Last Updated
November 26, 2013
Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02000323
Brief Title
Early Enteral Nutrition in Severe Acute Pancreatitis
Official Title
Early Enteral Nutrition in Severe Acute Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
pancreatitis, enteral nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
early enteral nutrition
Arm Type
Active Comparator
Arm Description
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.
Arm Title
modified early enteral nutrition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
early enteral nutrition
Intervention Description
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
Intervention Name(s)
modified early enteral nutrition
Intervention Description
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.
Primary Outcome Measure Information:
Title
mortality
Description
the rate of patients died
Time Frame
28days
Secondary Outcome Measure Information:
Title
operation rate
Description
The rate of patients received operation for pancreatitis debridement
Time Frame
2 months
Title
fulfilling enteral nutrition target（≥25Kcal/kg/day）
Description
enteral nutrition target set as ≥25Kcal/kg/day
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
inta-abdominal infection
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Er chen, PHD
Phone
64370045
Ext
665520
Email
chenerzhen@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
qiang En mao
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang en Mao, phd
Organizational Affiliation
Emergency intensive care unit of Ruijin Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wen xu, Master
Organizational Affiliation
doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Er Chen, PHD
Phone
64370045
Ext
665590
Email
elmaxuwen@gmail.com
First Name & Middle Initial & Last Name & Degree
xu Wen

12. IPD Sharing Statement

Citations:
PubMed Identifier
22908969
Citation
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.
Results Reference
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Early Enteral Nutrition in Severe Acute Pancreatitis

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