The Impact of Early Enteral Nutrition on the Clinical Outcomes of Severe Acute Pancreatitis Patients: A Randomized Control Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- All cause mortality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: early enteral nutrition (Dietary Supplement)
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.
Intervention: Parenteral nutrition (Dietary Supplement)
Outcomes
Primary Outcomes
All cause mortality
Time Frame: Three months
Secondary Outcomes
- Pancreatic sepsis(Three months)
- Length of hospitalization(From admission to discharge)
- Operation ratio(From admission to discharge)
- Cost of hospitalization(From admission to discharge)