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Medium Calorie Parenteral Nutrition on Patients With Gastrointestinal Cancer Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT01700062
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
JUI-FEN CHUANG, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Neoplasms Dietary Supplement: Total Parenteral Nutrition (TPN) Phase 4

Detailed Description:
biochemistry data Various inflammation-related cytokines clinical outcome hospital stay
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Assessment the Effect of Medium-Calorie TPN on Patients With Gastrointestinal Cancer Undergoing Surgery
Study Start Date : April 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. biochemistry data; Various inflammation-related cytokines ; [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. clinical outcome(hospital stay..) [ Time Frame: 2 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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): NCT01700062


Locations
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Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 80756
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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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
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Responsible Party: JUI-FEN CHUANG, Department of pharmacy, leader, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01700062    
Other Study ID Numbers: KMUH-IRB-960022
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012
Keywords provided by JUI-FEN CHUANG, Kaohsiung Medical University Chung-Ho Memorial Hospital:
medium-calorie
standard calorie
parenteral nutrition
Additional relevant MeSH terms:
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Colorectal Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases