Comparison of Three-chamber-bag Versus Compounded Bag

NCT ID: NCT01247740

Last Updated: 2012-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-10-31

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.

Conditions

Parenteral Nutrition for Patients With Proven Insufficient Enteral Resorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

three chamber bag for parenteral nutrition containing lipids, glucose, amino acids and electrolytes

Group Type: EXPERIMENTAL

NuTRIflex Lipid peri

Intervention Type: DRUG

parenteral nutrition

2

compounded monobag including lipids, glucose, amino acids and electrolytes

Group Type: ACTIVE_COMPARATOR

compounded monobag

Intervention Type: DRUG

parenteral nutrition

Interventions

NuTRIflex Lipid peri

parenteral nutrition

Intervention Type: DRUG

compounded monobag

parenteral nutrition

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianchun Yu, Prof.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital,Department of Gastrointestinal Surgery

Locations

Peking Union Medical College Hospital,Department of Gastrointestinal Surgery

Beijing, , China

Countries

China

Other Identifiers

HC-G-H-0805

Identifier Type: -

Identifier Source: org_study_id