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Comparison of Three-chamber-bag Versus Compounded Bag

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01247740
Enrollment
240
Registered
2010-11-24
Start date
2010-10-31
Completion date
2011-10-31
Last updated
2012-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenteral Nutrition for Patients With Proven Insufficient Enteral Resorption

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.

Interventions

DRUGNuTRIflex Lipid peri

parenteral nutrition

DRUGcompounded monobag

parenteral nutrition

Sponsors

B. Braun Melsungen AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Course of prealbumin (from day 1 to day 7)7 days

Secondary

MeasureTime frame
clinical outcome parameters, haematology, liver function, blood biochemistry and electrolytes, coagulation function7 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026