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Early Enteral Nutrition for Severe Acute Pancreatitis

Primary Purpose

Acute Necrotizing Pancreatitis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
early enteral nutrition
Parenteral nutrition
Sponsored by
Sichuan Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Necrotizing Pancreatitis focused on measuring Acute severe pancreatitis, nutritional support, enteral nutrition, parenteral nutrition

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of severe acute pancreatitis
  • Consent informed

Exclusion Criteria:

  • Diabetes mellitus
  • Allergy for any ingredient of PN or EN regimen
  • Pregnancy

Sites / Locations

  • Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early enteral nutrition

Control: Parenteral Nutrition

Arm Description

Twenty patient will be enrolled into this arm. Enteral nutrition administration will start within 24 hours after admission through naso-jejunal tube and continue for 7 days after admission.Naso-jejunal tube will be set up by endoscopy.

Twenty patient will be enrolled into this arm. PN administration will start within 24 hours after admission and continue for 7 days after admission.Parenteral nutrition will be administered through subclavian central venous catheter.

Outcomes

Primary Outcome Measures

All cause mortality

Secondary Outcome Measures

Pancreatic sepsis
Length of hospitalization
Operation ratio
Cost of hospitalization

Full Information

First Posted
October 11, 2009
Last Updated
November 29, 2010
Sponsor
Sichuan Academy of Medical Sciences
Collaborators
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00995098
Brief Title
Early Enteral Nutrition for Severe Acute Pancreatitis
Official Title
The Impact of Early Enteral Nutrition on the Clinical Outcomes of Severe Acute Pancreatitis Patients: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sichuan Academy of Medical Sciences
Collaborators
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is increasing evidence that indicates early enteral nutrition may be associated with improved outcome in acute pancreatitis patients. However, most of the clinical trials regarding this targeted mild to moderated pancreatitis patients. In regard to severe acute pancreatitis (SAP) patients, current results from randomized control trials (RCTs) are inconclusive. The researchers of this study aim to investigate the impact of early enteral nutrition 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
Acute Necrotizing Pancreatitis
Keywords
Acute severe pancreatitis, nutritional support, enteral nutrition, parenteral nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early enteral nutrition
Arm Type
Experimental
Arm Description
Twenty patient will be enrolled into this arm. Enteral nutrition administration will start within 24 hours after admission through naso-jejunal tube and continue for 7 days after admission.Naso-jejunal tube will be set up by endoscopy.
Arm Title
Control: Parenteral Nutrition
Arm Type
Active Comparator
Arm Description
Twenty patient will be enrolled into this arm. PN administration will start within 24 hours after admission and continue for 7 days after admission.Parenteral nutrition will be administered through subclavian central venous catheter.
Intervention Type
Dietary Supplement
Intervention Name(s)
early enteral nutrition
Other Intervention Name(s)
Nutrison Fibre
Intervention Description
Enteral nutrition will be administered within 24 hours of admission through naso-jejunal tube and continue for 7 days after admission. Naso-jejunal tube will be set up by endoscopy. X-ray will be used to place the distal end of the feeding tube and EN would not start until the distal end of the feeding tube has been placed at the remote end of Treitz ligament. Standard enteral nutrition liquid regimen (Nutrison Fibre) will be used. Patients are targeted to receive calories for 25 kcal/kg/day and nitrogen for 0.2g/kg/day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Parenteral nutrition
Other Intervention Name(s)
Lipovenoes(LCT/MCT fat emulsion, 20%), Novamin (11.4%)
Intervention Description
PN administration will start within 12 hours of admission and continue for 7 days after admission. Patients will receive calories for 25 kcal/kg and nitrogen for 0.2g/kg. Twenty percent of the calories will be provided by fat emulsion (LCT/MCT) and the remaining will be provided by dextrose. Nitrogen will be provided by balanced amino acids injection (Novamin). All PN components will be compounded into 3-liters bags under sterile conditions. Nutrition regimen will be administered through subclavian central venous catheter.
Primary Outcome Measure Information:
Title
All cause mortality
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Pancreatic sepsis
Time Frame
Three months
Title
Length of hospitalization
Time Frame
From admission to discharge
Title
Operation ratio
Time Frame
From admission to discharge
Title
Cost of hospitalization
Time Frame
From admission to discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of severe acute pancreatitis Consent informed Exclusion Criteria: Diabetes mellitus Allergy for any ingredient of PN or EN regimen Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Cai, M.D
Organizational Affiliation
Sichuan Academy of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hua Jiang, M.D
Organizational Affiliation
Sichuan Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Zeng, M.D
Organizational Affiliation
Sichuan Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
15175229
Citation
Marik PE, Zaloga GP. Meta-analysis of parenteral nutrition versus enteral nutrition in patients with acute pancreatitis. BMJ. 2004 Jun 12;328(7453):1407. doi: 10.1136/bmj.38118.593900.55. Epub 2004 Jun 2.
Results Reference
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PubMed Identifier
12056792
Citation
Meier R, Beglinger C, Layer P, Gullo L, Keim V, Laugier R, Friess H, Schweitzer M, Macfie J; ESPEN Consensus Group. ESPEN guidelines on nutrition in acute pancreatitis. European Society of Parenteral and Enteral Nutrition. Clin Nutr. 2002 Apr;21(2):173-83. doi: 10.1054/clnu.2002.0543. No abstract available.
Results Reference
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PubMed Identifier
16517959
Citation
McClave SA, Chang WK, Dhaliwal R, Heyland DK. Nutrition support in acute pancreatitis: a systematic review of the literature. JPEN J Parenter Enteral Nutr. 2006 Mar-Apr;30(2):143-56. doi: 10.1177/0148607106030002143.
Results Reference
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Early Enteral Nutrition for Severe Acute Pancreatitis

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