Early Enteral Nutrition for Severe Acute Pancreatitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00995098|
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : November 30, 2010
|Condition or disease||Intervention/treatment||Phase|
|Acute Necrotizing Pancreatitis||Dietary Supplement: early enteral nutrition Dietary Supplement: Parenteral nutrition||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Early Enteral Nutrition on the Clinical Outcomes of Severe Acute Pancreatitis Patients: A Randomized Control Trial|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||October 2010|
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.
- All cause mortality [ Time Frame: Three months ]
- Pancreatic sepsis [ Time Frame: Three months ]
- Length of hospitalization [ Time Frame: From admission to discharge ]
- Operation ratio [ Time Frame: From admission to discharge ]
- Cost of hospitalization [ Time Frame: From admission to discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995098
|Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital|
|Chengdu, Sichuan, China, 610072|
|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|