Early Enteral Nutrition for Severe Acute Pancreatitis

Phase 4

Completed

• Conditions: Acute Necrotizing Pancreatitis
• Interventions: Dietary Supplement: early enteral nutrition; Dietary Supplement: Parenteral nutrition

• Registration Number: NCT00995098
• Lead Sponsor: Sichuan Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-11
• Study First Submitted QC: 2009-10-14
• Study First Posted: 2009-10-15
• Primary Completion: 2010-07
• Study Completion: 2010-10
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-29
• Last Update Posted: 2010-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Clinical diagnosis of severe acute pancreatitis
• Consent informed

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early enteral nutrition	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.
Control: Parenteral Nutrition	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.

Primary Outcome Measures

Name	Time	Method
All cause mortality	Three months

Secondary Outcome Measures

Name	Time	Method
Pancreatic sepsis	Three months
Length of hospitalization	From admission to discharge
Operation ratio	From admission to discharge
Cost of hospitalization	From admission to discharge

Trial Locations

Locations (1)

Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China