Early Enteral Nutrition for Severe Acute Pancreatitis

NCT00995098 | Completed Phase 4 DMC

• 1 other identifier: SAMS-080384
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Necrotizing Pancreatitis

Keywords

Acute severe pancreatitis; nutritional support; enteral nutrition; parenteral nutrition

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  Three months

Secondary Outcomes (4)

• Pancreatic sepsis

  Three months

• Length of hospitalization

  From admission to discharge

• Operation ratio

  From admission to discharge

• Cost of hospitalization

  From admission to discharge

Study Arms (2)

Early enteral nutrition

EXPERIMENTAL

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

Control: Parenteral Nutrition

ACTIVE COMPARATOR

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

Interventions

early enteral nutrition 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.

Also known as: Nutrison Fibre

Early enteral nutrition

Parenteral nutrition 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.

Also known as: Lipovenoes(LCT/MCT fat emulsion, 20%), Novamin (11.4%)

Control: Parenteral Nutrition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of severe acute pancreatitis
• Consent informed

You may not qualify if:

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

Sponsors & Collaborators

• Sichuan Academy of Medical Sciences: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

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

Chengdu, Sichuan, 610072, China

Location

Related 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. doi: 10.1136/bmj.38118.593900.55. Epub 2004 Jun 2.

  PMID: 15175229 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Hyperphagia

Interventions

Parenteral Nutrition; NovaMin

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Bin Cai, M.D

  Sichuan Academy of Medical Sciences

  STUDY DIRECTOR

• Hua Jiang, M.D

  Sichuan Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Jun Zeng, M.D

  Sichuan Academy of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2009
• First Posted: October 15, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 30, 2010

Record last verified: 2010-11

Locations

CN (1)