Early Enteral Nutrition in Severe Acute Pancreatitis

Pancreatitis Clinical Trial

Official title:

Early Enteral Nutrition in Severe Acute Pancreatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02000323
• Other study ID #: RJpancreatitis02
• Secondary ID: RJpancreatitis02
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2013
• Last updated: November 26, 2013
• Start date: August 2012
• Est. completion date: August 2017

Study information

• Verified date: November 2013
• Source: Ruijin Hospital
• Contact: Zhen Er chen, PHD
• Phone: 64370045
• Email: chenerzhen[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial Summary

to compare different time points for enteral nutrition in SAP patients

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pancreatitis

Intervention

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
• 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.

Locations

Country	Name	City	State
China	Ruijin	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	inta-abdominal infection		2 months	No
Primary	mortality	the rate of patients died	28days	Yes
Secondary	operation rate	The rate of patients received operation for pancreatitis debridement	2 months	No
Secondary	fulfilling enteral nutrition target(=25Kcal/kg/day)	enteral nutrition target set as =25Kcal/kg/day	7 days	No