MedDataX Logo

Medium Calorie Parenteral Nutrition on Patients With Gastrointestinal Cancer Undergoing Surgery

NCT ID: NCT01700062

Last Updated: 2012-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

biochemistry data Various inflammation-related cytokines clinical outcome hospital stay

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

medium-calorie standard calorie parenteral nutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Medium calorie

Group Type EXPERIMENTAL

Total Parenteral Nutrition (TPN)

Intervention Type DIETARY_SUPPLEMENT

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

standard calorie

Group Type EXPERIMENTAL

Total Parenteral Nutrition (TPN)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

JUI-FEN CHUANG

Department of pharmacy, leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

JF CHUANG, M.S.

Role: PRINCIPAL_INVESTIGATOR

Department of pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

JY WANG, M.D.

Role: STUDY_CHAIR

Departments of Surgery Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

YB HUANG, Ph.D.

Role: STUDY_DIRECTOR

Departments of Pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaohsiung Medical University Hospital

Kaohsiung City, Kaohsiung, Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KMUH-IRB-960022

Identifier Type: -

Identifier Source: org_study_id