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Comparison of Three-chamber-bag Versus Compounded Bag

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01247740
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : January 10, 2012
Information provided by (Responsible Party):
B. Braun Melsungen AG

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parenteral Nutrition for Patients With Proven Insufficient Enteral Resorption Drug: NuTRIflex Lipid peri Drug: compounded monobag Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: 1
three chamber bag for parenteral nutrition containing lipids, glucose, amino acids and electrolytes
Drug: NuTRIflex Lipid peri
parenteral nutrition

Active Comparator: 2
compounded monobag including lipids, glucose, amino acids and electrolytes
Drug: compounded monobag
parenteral nutrition

Primary Outcome Measures :
  1. Course of prealbumin (from day 1 to day 7) [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. clinical outcome parameters, haematology, liver function, blood biochemistry and electrolytes, coagulation function [ Time Frame: 7 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01247740

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Peking Union Medical College Hospital,Department of Gastrointestinal Surgery
Beijing, China
Sponsors and Collaborators
B. Braun Melsungen AG
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Principal Investigator: Jianchun Yu, Prof. Peking Union Medical College Hospital,Department of Gastrointestinal Surgery
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Responsible Party: B. Braun Melsungen AG Identifier: NCT01247740    
Other Study ID Numbers: HC-G-H-0805
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: January 2012