Medium Calorie Parenteral Nutrition on Patients With Gastrointestinal Cancer Undergoing Surgery

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700062
• Other study ID #: KMUH-IRB-960022
• Status: Completed
• Phase: Phase 4
• First received: October 2, 2012
• Last updated: October 2, 2012
• Start date: April 2007
• Est. completion date: December 2008

Study information

• Verified date: October 2012
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

biochemistry data Various inflammation-related cytokines clinical outcome hospital stay

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Gastrointestinal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biochemistry data; Various inflammation-related cytokines ;		7 days	Yes
Secondary	clinical outcome(hospital stay..)		2 months	Yes