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

Tracking Information

First Received Date ^ICMJE

October 2, 2012

Last Updated Date

October 2, 2012

Start Date ^ICMJE

April 2007

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Medium Calorie Parenteral Nutrition on Patients With Gastrointestinal Cancer Undergoing Surgery

Official Title ^ICMJE

Assessment the Effect of Medium-Calorie TPN on Patients With Gastrointestinal Cancer Undergoing Surgery

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

Detailed Description

biochemistry data Various inflammation-related cytokines clinical outcome hospital stay

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Colorectal Neoplasms

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Medium calorie
Intervention: Dietary Supplement: Total Parenteral Nutrition (TPN)
Experimental: standard calorie
Intervention: Dietary Supplement: Total Parenteral Nutrition (TPN)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01700062

Other Study ID Numbers ^ICMJE

KMUH-IRB-960022

Has Data Monitoring Committee

Yes

Responsible Party

JUI-FEN CHUANG, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Sponsor ^ICMJE

Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Kaohsiung Medical University Chung-Ho Memorial Hospital

Verification Date

October 2012

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

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