Early Enteral Nutrition in Severe Acute Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Ruijin Hospital
Sponsor:
Collaborator:
RenJi Hospital
Information provided by (Responsible Party):
Erzhen Chen, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT02000323
First received: November 5, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

to compare different time points for enteral nutrition in SAP patients


Condition Intervention
Pancreatitis
Other: early enteral nutrition
Other: modified early enteral nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Early Enteral Nutrition in Severe Acute Pancreatitis

Resource links provided by NLM:


Further study details as provided by Ruijin Hospital:

Primary Outcome Measures:
  • mortality [ Time Frame: 28days ] [ Designated as safety issue: Yes ]
    the rate of patients died


Secondary Outcome Measures:
  • operation rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The rate of patients received operation for pancreatitis debridement

  • fulfilling enteral nutrition target(≥25Kcal/kg/day) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    enteral nutrition target set as ≥25Kcal/kg/day


Other Outcome Measures:
  • inta-abdominal infection [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000323

Contacts
Contact: Zhen Er chen, PHD 64370045 ext 665520 chenerzhen@hotmail.com
Contact: qiang En mao

Locations
China, Shanghai
Ruijin Recruiting
Shanghai, Shanghai, China
Contact: Zhen Er Chen, PHD    64370045 ext 665590    elmaxuwen@gmail.com   
Principal Investigator: xu Wen         
Sponsors and Collaborators
Ruijin Hospital
RenJi Hospital
Investigators
Study Director: Qiang en Mao, phd Emergency intensive care unit of Ruijin Hospital
Principal Investigator: Wen xu, Master doctor
  More Information

Publications:
Responsible Party: Erzhen Chen, Prefessor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02000323     History of Changes
Other Study ID Numbers: RJpancreatitis02, RJpancreatitis02
Study First Received: November 5, 2013
Last Updated: November 26, 2013
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Ruijin Hospital:
pancreatitis
enteral nutrition

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 26, 2014