Early Enteral Nutrition for Severe Acute Pancreatitis - Full Text View

Purpose

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	Intervention	Phase
Acute Necrotizing Pancreatitis	Dietary Supplement: early enteral nutrition Dietary Supplement: Parenteral nutrition	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary pancreatitis

MedlinePlus related topics: Pancreatitis

Drug Information available for: Parenteral Nutrition, Total

U.S. FDA Resources

Further study details as provided by Sichuan Academy of Medical Sciences:

Primary Outcome Measures:

All cause mortality [ Time Frame: Three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pancreatic sepsis [ Time Frame: Three months ] [ Designated as safety issue: No ]
Length of hospitalization [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]
Operation ratio [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]
Cost of hospitalization [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]

Enrollment:	42
Study Start Date:	October 2009
Study Completion Date:	October 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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%)

Arms

Assigned Interventions

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 Name: 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%)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995098

Locations

China, Sichuan
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, Sichuan Provincial People's Hospital

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.

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. No abstract available.

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.

Responsible Party:	Bin Cai/Deputy Chief, Sichuan Academy of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00995098 History of Changes
Other Study ID Numbers:	SAMS-080384
Study First Received:	October 11, 2009
Last Updated:	November 29, 2010
Health Authority:	China: Ministry of Health

Keywords provided by Sichuan Academy of Medical Sciences:

Acute severe pancreatitis
nutritional support
enteral nutrition
parenteral nutrition

Additional relevant MeSH terms:

Pancreatitis
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013