Early Enteral Nutrition for Severe Acute Pancreatitis

Acute Necrotizing Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995098
• Other study ID #: SAMS-080384
• Status: Completed
• Phase: Phase 4
• First received: October 11, 2009
• Last updated: November 29, 2010
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Sichuan Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of severe acute pancreatitis

• Consent informed

Exclusion Criteria:

• Diabetes mellitus

• Allergy for any ingredient of PN or EN regimen

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Necrotizing Pancreatitis
• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Sichuan Academy of Medical Sciences	Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		Three months	No
Secondary	Pancreatic sepsis		Three months	No
Secondary	Length of hospitalization		From admission to discharge	No
Secondary	Operation ratio		From admission to discharge	No
Secondary	Cost of hospitalization		From admission to discharge	No