- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01247740
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
Status
Completed
Intervention / Treatment
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
-
-
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Beijing, China
- Peking Union Medical College Hospital,Department of Gastrointestinal Surgery
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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
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parenteral nutrition
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Active Comparator: 2
compounded monobag including lipids, glucose, amino acids and electrolytes
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parenteral nutrition
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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.
Sponsor
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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