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Completed

NCT Number: NCT00995098

Early Enteral Nutrition for Severe Acute Pancreatitis

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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Key information

Conditions

Acute Necrotizing Pancreatitis Digestive System Diseases Hyperphagia Pancreatic Diseases Pancreatitis Pancreatitis, Acute Necrotizing Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Chengdu, Sichuan, 610072, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of severe acute pancreatitis
  • Consent informed

Exclusion criteria

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

Treatment and study plan

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.

Other names: Nutrison Fibre

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.

Other names: Lipovenoes(LCT/MCT fat emulsion, 20%), Novamin (11.4%)

Primary outcomes

  1. All cause mortality

    Time frame: Three months

Secondary outcomes

  1. Pancreatic sepsis

    Time frame: Three months

  2. Length of hospitalization

    Time frame: From admission to discharge

  3. Operation ratio

    Time frame: From admission to discharge

  4. Cost of hospitalization

    Time frame: From admission to discharge

Sponsors and collaborators

Lead sponsor

Sichuan Academy of Medical Sciences

Other

Collaborators

  • Peking Union Medical College Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 15, 2009
Registry last updated
Nov 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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