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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
  Purpose

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


Condition Intervention Phase
Colorectal Neoplasms
 Dietary Supplement: Total Parenteral Nutrition (TPN)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Assessment the Effect of Medium-Calorie TPN on Patients With Gastrointestinal Cancer Undergoing Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • biochemistry data; Various inflammation-related cytokines ; [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical outcome(hospital stay..) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: April 2007
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medium calorie 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: standard calorie 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

Detailed Description:

biochemistry data Various inflammation-related cytokines clinical outcome hospital stay

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700062

Locations
Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 80756
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: JUI-FEN CHUANG, Department of pharmacy, leader, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01700062     History of Changes
Other Study ID Numbers: KMUH-IRB-960022
Study First Received: October 2, 2012
Last Updated: October 2, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
medium-calorie
standard calorie
parenteral nutrition

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013