Critical Ill Patient Undergone Parenteral NutritionNCT02035943
Tight Glycemic Control and Insulin Administration During Parenteral Nutrition
A study testing Insulin separated and Insulin added to parenteral nutrition in people with Critical Ill Patient Undergone Parenteral Nutrition, run by Policlinico Hospital at 1 site in Italy.
Trial summary
In this study the investigators want to comare safety and efficacy of two different metods to administrate insulin during parenteral nutrition. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critical Ill Patient Undergone Parenteral Nutrition
- What is being tested?
- Insulin separated and Insulin added to parenteral nutrition
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Dec 2008
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Critical ill patients undergone parenteral nutrition
Who cannot join
- Acute cerebral injury, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tight Glycemic Control and Insulin Administration During Parenteral Nutrition, in Critical Ill Patients
In this study the investigators want to comare safety and efficacy of two different metods to administrate insulin during parenteral nutrition.
Read the detailed description
In this study the investigators want to compare safety and efficacy of two different metods to administrate insulin during parenteral nutrition.
- Being tested
- Insulin separated, Insulin added to parenteral nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin separatedDietary supplement
separate continuos infusion of insulin
Insulin added to parenteral nutritionDietary supplement
Insulin added to parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Insulin separated | Active comparator | Seprated infusion of insulin Receives: Dietary Supplement: Insulin separated |
| Insulin added to parenteral nutrition | Active comparator | Insulin added to parenteral nutrition Receives: Dietary Supplement: Insulin added to parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of glucose level control out of range (80-110 mg/dl)
Measured: ICU stay (a week on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Ill Patient Undergone Parenteral NutritionStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Chiumello, Policlinico Hospital
- Investigators
- Sergio De Chiara, MD, Principal investigator, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035943
- Sponsor's protocol ID
- 127
- Status last verified
- Jan 2014
- First submitted
- 1 Dec 2011
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Glycemic Control and Insulin Administration During Parenteral Nutrition, in Critical Ill Patients
- ClinicalTrials.gov ID
- NCT02035943
- Acronym / sponsor ID
- 127
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Jan 2014 (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.
In this study the investigators want to comare safety and efficacy of two different metods to administrate insulin during parenteral nutrition.
Detailed description
In this study the investigators want to compare safety and efficacy of two different metods to administrate insulin during parenteral nutrition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin separated | Active comparator | Dietary Supplement: Insulin separatedSeprated infusion of insulin |
| Insulin added to parenteral nutrition | Active comparator | Dietary Supplement: Insulin added to parenteral nutritionInsulin added to parenteral nutrition |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Critical ill patients undergone parenteral nutrition
Key exclusion criteria (1 listed)
- Acute cerebral injury, pregnancy
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 |
|---|---|---|
| Insulin separatedseparate continuos infusion of insulin | Dietary supplement | Insulin separated |
| Insulin added to parenteral nutritionInsulin added to parenteral nutrition | Dietary supplement | Insulin added to parenteral nutrition |
Primary outcome
Number of glucose level control out of range (80-110 mg/dl)
Time frame: ICU stay (a week on average)
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 14 Jan 2014.
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.
Sergio De Chiara, MD principal investigator
Policlinico Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin separated and Insulin added to parenteral nutrition in people with Critical Ill Patient Undergone Parenteral Nutrition, run by Policlinico Hospital at 1 site in Italy.
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 1 inclusion and 1 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 14 Jan 2014. 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 Italy. 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.
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?
Number of glucose level control out of range (80-110 mg/dl) (time frame: ICU stay (a week on average)). 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 14 Jan 2014.