Critical IllnessAldea _01NCT00735163
Blood Glucose Control With A Software-Algorithm In Intensive Care Unit (ICU) Patients
A study of Critical Illness, run by B. Braun Melsungen AG at 1 site in Austria.
Trial summary
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Recently, large randomized controlled trials have demonstrated that tight glycaemic control (TGC) reduces morbidity and mortality in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2008to Feb 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: > 18 years of age
- Stay in the ICU expected to be > 120 h
- Blood glucose > 110 mg/dl or patient on insulin treatment
Who cannot join
- Patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
- Known or suspected allergy to insulin
- Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
- Moribund patients likely to die within 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mono-Centric, Open, Non-Controlled Study To Investigate The Feasibility Of Blood Glucose Control With The Software-Algorithm eMPC (Enhanced Model Predictive Control) In ICU Patients
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Recently, large randomized controlled trials have demonstrated that tight glycaemic control (TGC) reduces morbidity and mortality in this population. Based on this emerging evidence intensive insulin therapy is currently finding its way into the critical care practice.
In the meantime numerous insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented. Recent reviews comparing different types of protocols describe widely ranging practice and difficulties in achieving TGC despite extensive efforts of the intensive care unit (ICU) staff. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. The primary objective of the current study is to investigate the performance (efficacy) of a control algorithm for glycaemic control in ICU patients for the whole length of ICU stay.
- Conditions
- Critical Illness
- Being tested
- enhanced model predictive control algorithm (eMPC)
- Keywords
- algorithm, tight glycemic control, glucose control, intensive care, insulin, ICU
- Medical subject headings
- Critical Illness, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced model predictive control algorithm (eMPC)Other
eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | improved model predictive control algorithm (eMPC) for glycaemic control in ICU patients Receives: Other: enhanced model predictive control algorithm (eMPC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of time within the predefined glucose target range of 80-110 mg/dL
Measured: from start of treatment to the last glucose measurement under treatment
Secondary outcomes (3)
hypoglycemias (lab) and possible attendant clinical symptoms (e.g. convulsions)
Measured: from start of treatment to the last glucose measurement under treatment
Usability parameters like convenience of alarming function; workload; blood sampling frequency
Measured: from start of treatment to the last glucose measurement under treatment
Concomitant medication including insulin infusion rate, parenteral/enteral nutrition
Measured: from start of treatment to the last glucose measurement under treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas R Pieber, Prof. Dr., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735163
- Sponsor's protocol ID
- HC-G-H-0806
- Acronym
- Aldea _01
- Status last verified
- Apr 2009
- First submitted
- 13 Aug 2008
- Last updated
- 16 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Plank J, Blaha J, Cordingley J, Wilinska ME, Chassin LJ, Morgan C, Squire S, Haluzik M, Kremen J, Svacina S, Toller W, Plasnik A, Ellmerer M, Hovorka R, Pieber TR. Multicentric, randomized, controlled trial to evaluate blood glucose control by the model predictive control algorithm versus routine glucose management protocols in intensive care unit patients. Diabetes Care. 2006 Feb;29(2):271-6. doi: 10.2337/diacare.29.02.06.dc05-1689.
PubMed 16443872Pachler C, Plank J, Weinhandl H, Chassin LJ, Wilinska ME, Kulnik R, Kaufmann P, Smolle KH, Pilger E, Pieber TR, Ellmerer M, Hovorka R. Tight glycaemic control by an automated algorithm with time-variant sampling in medical ICU patients. Intensive Care Med. 2008 Jul;34(7):1224-30. doi: 10.1007/s00134-008-1033-8. Epub 2008 Feb 23.
PubMed 18297268
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mono-Centric, Open, Non-Controlled Study To Investigate The Feasibility Of Blood Glucose Control With The Software-Algorithm eMPC (Enhanced Model Predictive Control) In ICU Patients
- ClinicalTrials.gov ID
- NCT00735163
- Acronym / sponsor ID
- Aldea _01 / HC-G-H-0806
- Conditions
- Critical Illness
- Keywords
- algorithm, tight glycemic control, glucose control, intensive care, insulin, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 14 Aug 2008 (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.
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Recently, large randomized controlled trials have demonstrated that tight glycaemic control (TGC) reduces morbidity and mortality in this population. Based on this emerging evidence intensive insulin therapy is currently finding its way into the critical care practice.
In the meantime numerous insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented. Recent reviews comparing different types of protocols describe widely ranging practice and difficulties in achieving TGC despite extensive efforts of the intensive care unit (ICU) staff. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. The primary objective of the current study is to investigate the performance (efficacy) of a control algorithm for glycaemic control in ICU patients for the whole length of ICU stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: enhanced model predictive control algorithm (eMPC)improved model predictive control algorithm (eMPC) for glycaemic control in ICU patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: > 18 years of age
- Stay in the ICU expected to be > 120 h
- Blood glucose > 110 mg/dl or patient on insulin treatment
Key exclusion criteria (4 listed)
- Patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
- Known or suspected allergy to insulin
- Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
- Moribund patients likely to die within 24 hours
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 |
|---|---|---|
| enhanced model predictive control algorithm (eMPC)eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control | Other | A |
Primary outcome
percentage of time within the predefined glucose target range of 80-110 mg/dL
Time frame: from start of treatment to the last glucose measurement under treatment
3 secondary outcomes
hypoglycemias (lab) and possible attendant clinical symptoms (e.g. convulsions)
Time frame: from start of treatment to the last glucose measurement under treatment
Usability parameters like convenience of alarming function; workload; blood sampling frequency
Time frame: from start of treatment to the last glucose measurement under treatment
Concomitant medication including insulin infusion rate, parenteral/enteral nutrition
Time frame: from start of treatment to the last glucose measurement under treatment
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 16 Apr 2009.
- Background: PubMed 16443872Plank J, Blaha J, Cordingley J, Wilinska ME, Chassin LJ, Morgan C, Squire S, Haluzik M, Kremen J, Svacina S, Toller W, Plasnik A, Ellmerer M, Hovorka R, Pieber TR. Multicentric, randomized, controlled trial to evaluate blood glucose control by the model predictive control algorithm versus routine glucose management protocols in intensive care unit patients. Diabetes Care. 2006 Feb;29(2):271-6. doi: 10.2337/diacare.29.02.06.dc05-1689.
- Background: PubMed 18297268Pachler C, Plank J, Weinhandl H, Chassin LJ, Wilinska ME, Kulnik R, Kaufmann P, Smolle KH, Pilger E, Pieber TR, Ellmerer M, Hovorka R. Tight glycaemic control by an automated algorithm with time-variant sampling in medical ICU patients. Intensive Care Med. 2008 Jul;34(7):1224-30. doi: 10.1007/s00134-008-1033-8. Epub 2008 Feb 23.
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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.
Thomas R Pieber, Prof. Dr. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Critical Illness, run by B. Braun Melsungen AG at 1 site in Austria.
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 3 inclusion and 4 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 16 Apr 2009. 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 Austria. 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?
percentage of time within the predefined glucose target range of 80-110 mg/dL (time frame: from start of treatment to the last glucose measurement under treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00735163, which also lists 2 linked publications.
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 16 Apr 2009.