NCT01247740CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- B. Braun Melsungen AG
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Course of prealbumin (from day 1 to day 7)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Experimental
three chamber bag for parenteral nutrition containing lipids, glucose, amino acids and electrolytes
Intervention: NuTRIflex Lipid peri (Drug)
2
Active Comparator
compounded monobag including lipids, glucose, amino acids and electrolytes
Intervention: compounded monobag (Drug)
Outcomes
Primary Outcomes
Course of prealbumin (from day 1 to day 7)
Time Frame: 7 days
Secondary Outcomes
- clinical outcome parameters, haematology, liver function, blood biochemistry and electrolytes, coagulation function(7 days)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)Graft Versus Host DiseaseNCT00366145Mesoblast, Inc.260
Active, not recruiting
Phase 3
A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intolerance to bDMARDsRheumatoid ArthritisNCT06020144Hangzhou Highlightll Pharmaceutical Co., Ltd459
Completed
Phase 3
A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque PsoriasisPlaque PsoriasisNCT03759197Therapeutics, Inc.206
Completed
Phase 3
A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor SymptomsMenopauseNCT01942668TherapeuticsMD1,845
Completed
Phase 3
Study of NV-101 for Efficacy, Pharmacodynamics, and Safety in Dental Patients Undergoing Mandibular ProceduresAnesthesia, DentalNCT00309361Novalar Pharmaceuticals, Inc.240