Early Enteral Nutrition for Severe Acute Pancreatitis

• Sponsor: Sichuan Academy of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00995098
• Collaborator: Peking Union Medical College Hospital (Other)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 3.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Necrotizing Pancreatitis	Dietary Supplement: early enteral nutrition; Dietary Supplement: Parenteral nutrition	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Impact of Early Enteral Nutrition on the Clinical Outcomes of Severe Acute Pancreatitis Patients: A Randomized Control Trial
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: 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.; Other Names: Nutrison Fibre
Active Comparator: 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.	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.; Other Names: Lipovenoes(LCT/MCT fat emulsion, 20%) Novamin (11.4%)

Outcome Measures

Primary Outcome Measures

1. All cause mortality [Three months]

Secondary Outcome Measures

1. Pancreatic sepsis [Three months]

2. Length of hospitalization [From admission to discharge]

3. Operation ratio [From admission to discharge]

4. Cost of hospitalization [From admission to discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of severe acute pancreatitis

• Consent informed

Exclusion Criteria:

• Diabetes mellitus

• Allergy for any ingredient of PN or EN regimen

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital	Chengdu	Sichuan	China	610072

Sponsors and Collaborators

• Sichuan Academy of Medical Sciences
• Peking Union Medical College Hospital

Investigators

• Study Director: Bin Cai, M.D, Sichuan Academy of Medical Sciences
• Principal Investigator: Hua Jiang, M.D, Sichuan Academy of Medical Sciences
• Study Chair: Jun Zeng, M.D, Sichuan Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

• Marik PE, Zaloga GP. Meta-analysis of parenteral nutrition versus enteral nutrition in patients with acute pancreatitis. BMJ. 2004 Jun 12;328(7453):1407. Epub 2004 Jun 2. Review.
• 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. Review.
• 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. Review.

• ClinicalTrials.gov Identifier: NCT00995098
• Other Study ID Numbers: SAMS-080384
• First Posted: Oct 15, 2009
• Last Update Posted: Nov 30, 2010
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: Acute severe pancreatitis; nutritional support; enteral nutrition; parenteral nutrition
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Acute Necrotizing

Study Results

No Results Posted as of Nov 30, 2010