Early Enteral Nutrition for Severe Acute Pancreatitis

NCT00995098 — Phase 4, Completed, 42 participants, Sichuan Academy of Medical Sciences

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The Impact of Early Enteral Nutrition on the Clinical Outcomes of Severe Acute Pancreatitis Patients: A Randomized Control Trial

Registry	NCT00995098
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	42 (Actual)
Sponsor	Sichuan Academy of Medical Sciences (Other); collaborators: Peking Union Medical College Hospital
Conditions	Acute Necrotizing Pancreatitis
Interventions	early enteral nutrition, Parenteral nutrition (Dietary supplement)
Dates	start 2009-10-01, primary completion 2010-07-01, completion 2010-10-01, first posted 2009-10-15, last updated 2010-11-30
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Early enteral nutrition	Experimental	Dietary Supplement: 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.
Control: Parenteral Nutrition	Active comparator	Dietary Supplement: 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.

early enteral nutrition (Dietary supplement), also known as Nutrison Fibre: 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.
Parenteral nutrition (Dietary supplement), also known as Lipovenoes(LCT/MCT fat emulsion, 20%), Novamin (11.4%): 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.

+Outcome measures

Primary outcomes

All cause mortality [Three months]

Secondary outcomes

Pancreatic sepsis [Three months]
Length of hospitalization [From admission to discharge]
Operation ratio [From admission to discharge]
Cost of hospitalization [From admission to discharge]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* Clinical diagnosis of severe acute pancreatitis
* Consent informed

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital	Chengdu, Sichuan	China

+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. doi: 10.1136/bmj.38118.593900.55. Epub 2004 Jun 2. PMID 15175229
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. PMID 12056792
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. PMID 16517959

+Investigators

Bin Cai, M.D, Study director, Sichuan Academy of Medical Sciences
Hua Jiang, M.D, Principal investigator, Sichuan Academy of Medical Sciences
Jun Zeng, M.D, Study chair, Sichuan Academy of Medical Sciences