Early Enteral Nutrition in Severe Acute Pancreatitis

Not Applicable

• Conditions: Pancreatitis
• Interventions: Other: early enteral nutrition; Other: modified early enteral nutrition

• Registration Number: NCT02000323
• Lead Sponsor: Ruijin Hospital

Brief Summary

to compare different time points for enteral nutrition in SAP patients

Detailed Description

There is increasing evidence that indicates Early Enteral Nutrition（EEN） may be associated with improved outcome in acute pancreatitis patients. However, some SAP patients failed to EEN. The researchers of this study aim to investigate the opportunity of EEN on the clinical outcomes of SAP patients.

Study Timeline

• Study Start: 2012-08
• Status Verified: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-26
• Last Update Submitted: 2013-11-26
• Study First Posted: 2013-12-04
• Last Update Posted: 2013-12-04
• Primary Completion: 2016-09
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase
2. Onset of abdominal pain within <=72h before admission
3. moderate severe or severe Acute Pancreatitis according to Atlanta criteria revisited in 2012 ffff

Exclusion Criteria

• 1. Pregnancy 2.tumor 3. acute onset of chronic pancreatitis

4. chronic disease of any organ （heart lung gastrointestinal renal etc.） 5. Pre-existing disease with life expectancy < 3 months 7.receive parenteral nutrition or enteral nutrition before admitting

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
early enteral nutrition	early enteral nutrition	Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. * The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. * After catharsis, Standard enteral nutrition liquid regimen （Peptisorb Liquid）will be used step by step. * Patients are targeted to receive calories for 25 kcal/kg/day.
modified early enteral nutrition	modified early enteral nutrition	Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission. * The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray. * After catharsis, Only Normal Saline were given through Naso-gastro-Jejunal tube until 2 or more followed requirements were met mean arterial pressure≥65mmHg; oxygenation index≥ 300;APCHEII≤8; intra-abdominal pressure \<20mmHg).Then Standard enteral nutrition liquid regimen (Peptisorb Liquid) will be used step by step. * Patients are targeted to receive calories for 25 kcal/kg/day.

Primary Outcome Measures

Name	Time	Method
mortality	28days	the rate of patients died

Secondary Outcome Measures

Name	Time	Method
operation rate	2 months	The rate of patients received operation for pancreatitis debridement
fulfilling enteral nutrition target（≥25Kcal/kg/day）	7 days	enteral nutrition target set as ≥25Kcal/kg/day

Trial Locations

Locations (1)

Ruijin; 🇨🇳 Shanghai, Shanghai, China