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Comparison of Three-chamber-bag Versus Compounded Bag

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01247740
First received: November 23, 2010
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Parenteral Nutrition for Patients With Proven Insufficient Enteral Resorption
 Drug: NuTRIflex Lipid peri
Drug: compounded monobag
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • Course of prealbumin (from day 1 to day 7) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical outcome parameters, haematology, liver function, blood biochemistry and electrolytes, coagulation function [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247740

Locations
China
Peking Union Medical College Hospital,Department of Gastrointestinal Surgery
Beijing, China
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
Principal Investigator: Jianchun Yu, Prof. Peking Union Medical College Hospital,Department of Gastrointestinal Surgery
  More Information

No publications provided

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01247740     History of Changes
Other Study ID Numbers: HC-G-H-0805
Study First Received: November 23, 2010
Last Updated: January 9, 2012
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013