Early Enteral Nutrition for Severe Acute Pancreatitis

This study has been completed.
Sponsor:
Collaborator:
Peking Union Medical College Hospital
Information provided by:
Sichuan Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00995098
First received: October 11, 2009
Last updated: November 29, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Acute Necrotizing Pancreatitis
Dietary Supplement: early enteral nutrition
Dietary Supplement: Parenteral nutrition
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Early Enteral Nutrition on the Clinical Outcomes of Severe Acute Pancreatitis Patients: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Sichuan Academy of Medical Sciences:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: Three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pancreatic sepsis [ Time Frame: Three months ] [ Designated as safety issue: No ]
  • Length of hospitalization [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]
  • Operation ratio [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]
  • Cost of hospitalization [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Dietary Supplement: early enteral nutrition
Enteral nutrition will be administered within 24 hours of admission through naso-jejunal tube and continue for 7 days after admission. Naso-jejunal tube will be set up by endoscopy. X-ray will be used to place the distal end of the feeding tube and EN would not start until the distal end of the feeding tube has been placed at the remote end of Treitz ligament. Standard enteral nutrition liquid regimen (Nutrison Fibre) will be used. Patients are targeted to receive calories for 25 kcal/kg/day and nitrogen for 0.2g/kg/day.
Other Name: Nutrison Fibre
Active Comparator: Control: 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.
Dietary Supplement: Parenteral nutrition
PN administration will start within 12 hours of admission and continue for 7 days after admission. Patients will receive calories for 25 kcal/kg and nitrogen for 0.2g/kg. Twenty percent of the calories will be provided by fat emulsion (LCT/MCT) and the remaining will be provided by dextrose. Nitrogen will be provided by balanced amino acids injection (Novamin). All PN components will be compounded into 3-liters bags under sterile conditions. Nutrition regimen will be administered through subclavian central venous catheter.
Other Names:
  • Lipovenoes(LCT/MCT fat emulsion, 20%)
  • Novamin (11.4%)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of severe acute pancreatitis
  • Consent informed

Exclusion Criteria:

  • Diabetes mellitus
  • Allergy for any ingredient of PN or EN regimen
  • Pregnancy
  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: NCT00995098

Locations
China, Sichuan
Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Sponsors and Collaborators
Sichuan Academy of Medical Sciences
Peking Union Medical College Hospital
Investigators
Study Director: Bin Cai, M.D Sichuan Academy of Medical Sciences
Principal Investigator: Hua Jiang, M.D Sichuan Academy of Medical Sciences
Study Chair: Jun Zeng, M.D Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital
  More Information

Publications:
Responsible Party: Bin Cai/Deputy Chief, Sichuan Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT00995098     History of Changes
Other Study ID Numbers: SAMS-080384
Study First Received: October 11, 2009
Last Updated: November 29, 2010
Health Authority: China: Ministry of Health

Keywords provided by Sichuan Academy of Medical Sciences:
Acute severe pancreatitis
nutritional support
enteral nutrition
parenteral nutrition

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Acute Necrotizing
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014