Parenteral Nutrition for Patients With Proven Insufficient Enteral ResorptionPhase 3NCT01247740
Comparison of Three-chamber-bag Versus Compounded Bag
A Phase 3 study testing NuTRIflex Lipid peri and compounded monobag in people with Parenteral Nutrition for Patients With Proven Insufficient Enteral Resorption, run by B. Braun Melsungen AG at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parenteral Nutrition for Patients With Proven Insufficient Enteral Resorption
- What is being tested?
- NuTRIflex Lipid peri and compounded monobag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital,Department of Gastrointestinal Surgery
Beijing
About this study
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
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.
- Being tested
- NuTRIflex Lipid peri, compounded monobag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuTRIflex Lipid periDrug
parenteral nutrition
compounded monobagDrug
parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | three chamber bag for parenteral nutrition containing lipids, glucose, amino acids and electrolytes Receives: Drug: NuTRIflex Lipid peri |
| 2 | Active comparator | compounded monobag including lipids, glucose, amino acids and electrolytes Receives: Drug: compounded monobag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of prealbumin (from day 1 to day 7)
Measured: 7 days
Secondary outcomes (1)
clinical outcome parameters, haematology, liver function, blood biochemistry and electrolytes, coagulation function
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenteral Nutrition for Patients With Proven Insufficient Enteral ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianchun Yu, Prof., Principal investigator, Peking Union Medical College Hospital,Department of Gastrointestinal Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247740
- Sponsor's protocol ID
- HC-G-H-0805
- Status last verified
- Jan 2012
- First submitted
- 23 Nov 2010
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01247740
- Acronym / sponsor ID
- HC-G-H-0805
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NuTRIflex Lipid perithree chamber bag for parenteral nutrition containing lipids, glucose, amino acids and electrolytes |
| 2 | Active comparator | Drug: compounded monobagcompounded monobag including lipids, glucose, amino acids and electrolytes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuTRIflex Lipid periparenteral nutrition | Drug | 1 |
| compounded monobagparenteral nutrition | Drug | 2 |
Primary outcome
Course of prealbumin (from day 1 to day 7)
Time frame: 7 days
1 secondary outcome
clinical outcome parameters, haematology, liver function, blood biochemistry and electrolytes, coagulation function
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianchun Yu, Prof. principal investigator
Peking Union Medical College Hospital,Department of Gastrointestinal Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NuTRIflex Lipid peri and compounded monobag in people with Parenteral Nutrition for Patients With Proven Insufficient Enteral Resorption, run by B. Braun Melsungen AG at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of prealbumin (from day 1 to day 7) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2012.