Medium Calorie Parenteral Nutrition on Patients With Gastrointestinal Cancer Undergoing Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JUI-FEN CHUANG, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01700062
First received: October 2, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted

October 2, 2012
October 2, 2012
April 2007
November 2008   (final data collection date for primary outcome measure)
biochemistry data; Various inflammation-related cytokines ; [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
clinical outcome(hospital stay..) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Medium Calorie Parenteral Nutrition on Patients With Gastrointestinal Cancer Undergoing Surgery
Assessment the Effect of Medium-Calorie TPN on Patients With Gastrointestinal Cancer Undergoing Surgery

aimed at investigating the efficacy, safety, and clinical outcome of Medium-Calorie or standard-calorie total parenteral nutrition (TPN) for patients with gastrointestinal cancer undergoing surgery

biochemistry data Various inflammation-related cytokines clinical outcome hospital stay

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Colorectal Neoplasms
Dietary Supplement: Total Parenteral Nutrition (TPN)
Medium calorie ,Nonprotein calories 20 Kcal/Kg/day,Protein 1g/Kg,Fat emulsion 0.5 g/kg/day D1-D6 post OP standard calorie, Nonprotein calories 30 Kcal/Kg/day,Protein 1.5 g/Kg,Fat emulsion 50g/day D1-D6 post OP
  • Experimental: Medium calorie
    Intervention: Dietary Supplement: Total Parenteral Nutrition (TPN)
  • Experimental: standard calorie
    Intervention: Dietary Supplement: Total Parenteral Nutrition (TPN)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients considered for major surgery for colorectal cancer Expected requirement for post operative PN or TPN of at least for 7 days Age >18 Hemodynamically stable Written Informed Consent

Exclusion Criteria:

  • Hemodynamic failure of any organ Renal insufficiency Patients with severe liver dysfunction Albumin < 3g/dL DM with poor blood sugar control
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01700062
KMUH-IRB-960022
Yes
JUI-FEN CHUANG, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Not Provided
Principal Investigator: JF CHUANG, M.S. Department of pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
Study Chair: JY WANG, M.D. Departments of Surgery Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
Study Director: YB HUANG, Ph.D. Departments of Pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP