Early Enteral Nutrition in Severe Acute Pancreatitis

to compare different time points for enteral nutrition in SAP patients

Study Overview

• Status: Unknown
• Conditions: Pancreatitis
• Intervention / Treatment: Other: early enteral nutrition; Other: modified early enteral nutrition

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen Er chen, PHD; Phone Number: 665520 64370045; Email: chenerzhen@hotmail.com
• Study Contact Backup: Name: qiang En mao

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Ruijin
      • Contact: Zhen Er Chen, PHD; Phone Number: 665590 64370045; Email: elmaxuwen@gmail.com
      • Principal Investigator: xu Wen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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 will be used step by step. Patients are targeted to receive calories for 25 kcal/kg/day. nutrition form: short peptide ,1 kcal/ml,target 200k kcal/day
Active Comparator: 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.	Other: 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 nasojejunal tube until 2 or more followed requirements were meted (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	the rate of patients died	28days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
inta-abdominal infection	2 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: RenJi Hospital
• Investigators: Study Director: Qiang en Mao, phd, Emergency intensive care unit of Ruijin Hospital; Principal Investigator: Wen xu, Master, Doctor

Publications and helpful links

General Publications

• Ong JP, Fock KM. Nutritional support in acute pancreatitis. J Dig Dis. 2012 Sep;13(9):445-52. doi: 10.1111/j.1751-2980.2012.00611.x.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): December 4, 2013

Study Record Updates

• Last Update Posted (Estimate): December 4, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: pancreatitis; enteral nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: RJpancreatitis02 (Other Identifier: RJH)