Early Enteral Nutrition for Severe Acute Pancreatitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Necrotizing Pancreatitis

Intervention / Treatment
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* Dietary Supplement: early enteral nutrition
* Dietary Supplement: Parenteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of severe acute pancreatitis Consent informed Exclusion Criteria: Diabetes mellitus Allergy for any ingredient of PN or EN regimen Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early enteral nutrition<br>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<br>* 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.<br>* Other names: Nutrison Fibre;|
| Active Comparator: Control: Parenteral Nutrition<br>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<br>* 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.<br>* Other names: Novamin (11.4%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic sepsis |  | Three months | 
| Length of hospitalization |  | From admission to discharge | 
| Operation ratio |  | From admission to discharge | 
| Cost of hospitalization |  | From admission to discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute severe pancreatitis, nutritional support, enteral nutrition, parenteral nutrition