Early Enteral Nutrition for Severe Acute Pancreatitis

NCT ID: NCT00995098

Last Updated: 2010-11-30

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Necrotizing Pancreatitis

Keywords

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Acute severe pancreatitis nutritional support enteral nutrition parenteral nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early enteral nutrition

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.

Group Type EXPERIMENTAL

early enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

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.

Control: Parenteral Nutrition

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.

Group Type ACTIVE_COMPARATOR

Parenteral nutrition

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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early enteral nutrition

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

Parenteral nutrition

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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Nutrison Fibre Lipovenoes(LCT/MCT fat emulsion, 20%) Novamin (11.4%)

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of severe acute pancreatitis
* Consent informed

Exclusion Criteria

* Diabetes mellitus
* Allergy for any ingredient of PN or EN regimen
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Sichuan Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sichuan Academy of Medical Sciences

Principal Investigators

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Bin Cai, M.D

Role: STUDY_DIRECTOR

Sichuan Academy of Medical Sciences

Hua Jiang, M.D

Role: PRINCIPAL_INVESTIGATOR

Sichuan Academy of Medical Sciences

Jun Zeng, M.D

Role: STUDY_CHAIR

Sichuan Academy of Medical Sciences

Locations

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

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 15175229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12056792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16517959 (View on PubMed)

Other Identifiers

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SAMS-080384

Identifier Type: -

Identifier Source: org_study_id