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OpenTrials
Completed

NCT Number: NCT01247740

Comparison of Three-chamber-bag Versus Compounded Bag

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking Union Medical College Hospital,Department of Gastrointestinal Surgery

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NuTRIflex Lipid peri

Drug

parenteral nutrition

compounded monobag

Drug

parenteral nutrition

Primary outcomes

  1. Course of prealbumin (from day 1 to day 7)

    Time frame: 7 days

Secondary outcomes

  1. clinical outcome parameters, haematology, liver function, blood biochemistry and electrolytes, coagulation function

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 24, 2010
Registry last updated
Jan 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.