Comparison of Three-chamber-bag Versus Compounded Bag

January 9, 2012 updated by: B. Braun Melsungen AG

A Prospective, Controlled, Randomized, Blinded, Parallel Group Multicentre Study on the Safety and Efficacy of a Convenience Three-chamber Bag for Parenteral Nutrition in Post-operative Patients After Abdominal Surgery Versus a Compounded Monobag

The purpose of the study is to investigate the efficacy and safety of a convenient 3-chamber-bag containing aminoacids, glucose and lipid emulsion (LCT/MCT 20%) compared to a conventionally compounded monobag for parenteral nutrition.

Study Overview

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

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

      • Beijing, China
        • Peking Union Medical College Hospital,Department of Gastrointestinal Surgery

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion: •Patients considered for elective open abdominal surgery

  • Male and female patients ≥18 and <85 years of age
  • Indication for total parenteral nutrition therapy: for 6 consecutive days
  • NRS ≥3
  • Ability and willingness to give voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Review Board (IRB) prior to all evaluations, and to comply with the requirements of the study

Exclusion: Major criteria:

  • Body weight < 50 kg or > 70 kg
  • Laparoscopic surgery
  • Seriously ill patients in need of high energy nutrition support (i. e. > 2100 Kcal/day)
  • Hepatic surgery
  • Surgery with estimated blood loss >1000ml
  • Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to the start of study
  • Receiving regular parenteral nutrition within 7 days before the onset of study
  • General contraindications for parenteral nutrition (acidosis of various geneses, untreated disorders of electrolyte and fluid balance, hyperhydration, acute pulmonary edema, inadequate cellular oxygen supply)
  • General contraindications for infusion therapy such as acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency, acute stroke
  • Known hypersensitivity to egg-, soy-, and peanut proteins or any of the ingredients

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
three chamber bag for parenteral nutrition containing lipids, glucose, amino acids and electrolytes
parenteral nutrition
Active Comparator: 2
compounded monobag including lipids, glucose, amino acids and electrolytes
parenteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Course of prealbumin (from day 1 to day 7)
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical outcome parameters, haematology, liver function, blood biochemistry and electrolytes, coagulation function
Time Frame: 7 days
7 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Jianchun Yu, Prof., Peking Union Medical College Hospital,Department of Gastrointestinal Surgery

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

October 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 23, 2010

First Posted (Estimate)

November 24, 2010

Study Record Updates

Last Update Posted (Estimate)

January 10, 2012

Last Update Submitted That Met QC Criteria

January 9, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • HC-G-H-0805

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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