Acute Necrotizing Pancreatitis
Conditions
Keywords
Acute severe pancreatitis, nutritional support, enteral nutrition, parenteral nutrition
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.
Interventions
DIETARY_SUPPLEMENTearly 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.
DIETARY_SUPPLEMENTParenteral 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.
Sponsors
Peking Union Medical College Hospital
Sichuan Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of severe acute pancreatitis * Consent informed
Exclusion criteria
* Diabetes mellitus * Allergy for any ingredient of PN or EN regimen * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality | Three months |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed