Medium Calorie Parenteral Nutrition on Patients With Gastrointestinal Cancer Undergoing Surgery

October 2, 2012 updated by: JUI-FEN CHUANG, Kaohsiung Medical University Chung-Ho Memorial Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

biochemistry data Various inflammation-related cytokines clinical outcome hospital stay

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Kaohsiung Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
biochemistry data; Various inflammation-related cytokines ;
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical outcome(hospital stay..)
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

October 4, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUH-IRB-960022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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