Critical IllnessAldea_02NCT00882427
Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit
A study of Critical Illness, run by B. Braun Melsungen AG at 1 site in United Kingdom.
Trial summary
Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated that tight blood glucose control in medical and surgical ICU patients results in a significant better outcome for the patients. 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 siteUnited Kingdom
- Study dates
- Mar 2009to Jul 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
- Admitted following cardiac surgery
- Stay in the ICU expected to be > 20h
- Blood glucose > 6.7 mmol/l within 4 hours of admission to intensive care or patient already receiving 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)
- Patients participating in another study
- Moribund patients likely to die within 24 hours
- Patients after organ transplantation within the last three months
- Patients under high dose cortisol treatment (cortisol > 1000 mg/day or equivalent doses of hydrocortisol)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton Hospital and Harefield NHS Trust
London
About this study
Official title: Single-center, Open Study on the Performance of the Software eMPC Algorithm Used for Blood Glucose Control Over an Extended Glucose Control Range (4.4 to 8.3 mmol/L) for a Maximum of 48 Hours in Postoperative Cardiac Surgery Patients in the Intensive Care Unit
Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated that tight blood glucose control in medical and surgical ICU patients results in a significant better outcome for the patients. Based on this emerging clinical evidence, there are increasing efforts worldwide to maintain strict glycaemic control in critically ill patients. However, achieving this goal requires extensive nursing efforts, including frequent bedside glucose monitoring and the implementation of complex intensive insulin infusion protocols. 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. This study will investigate the performance of an eMPC algorithm adjusted to target the range 4.4 - 8.3 mmol/L in line with the Surviving Sepsis guidelines.
- 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 |
|---|---|---|
| eMPC | 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 80-150 mg/dL
Measured: from start of treatment to the last glucose measurement under treatment
Secondary outcomes (3)
Hypoglycemias
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 posted16 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Jeremy Cordingley, Dr., Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882427
- Sponsor's protocol ID
- HC-G-H-0807
- Acronym
- Aldea_02
- Status last verified
- Feb 2010
- First submitted
- 15 Apr 2009
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Cordingley JJ, Vlasselaers D, Dormand NC, Wouters PJ, Squire SD, Chassin LJ, Wilinska ME, Morgan CJ, Hovorka R, Van den Berghe G. Intensive insulin therapy: enhanced Model Predictive Control algorithm versus standard care. Intensive Care Med. 2009 Jan;35(1):123-8. doi: 10.1007/s00134-008-1236-z. Epub 2008 Jul 26.
PubMed 18661120
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open Study on the Performance of the Software eMPC Algorithm Used for Blood Glucose Control Over an Extended Glucose Control Range (4.4 to 8.3 mmol/L) for a Maximum of 48 Hours in Postoperative Cardiac Surgery Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00882427
- Acronym / sponsor ID
- Aldea_02 / HC-G-H-0807
- 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
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Apr 2009 (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.
Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated that tight blood glucose control in medical and surgical ICU patients results in a significant better outcome for the patients. Based on this emerging clinical evidence, there are increasing efforts worldwide to maintain strict glycaemic control in critically ill patients. However, achieving this goal requires extensive nursing efforts, including frequent bedside glucose monitoring and the implementation of complex intensive insulin infusion protocols. 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. This study will investigate the performance of an eMPC algorithm adjusted to target the range 4.4 - 8.3 mmol/L in line with the Surviving Sepsis guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eMPC | 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 (4 listed)
- Age: > 18 years of age
- Admitted following cardiac surgery
- Stay in the ICU expected to be > 20h
- Blood glucose > 6.7 mmol/l within 4 hours of admission to intensive care or patient already receiving insulin treatment
Key exclusion criteria (7 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)
- Patients participating in another study
- 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 | eMPC |
Primary outcome
percentage of time within the predefined glucose target range of 80-150 mg/dL
Time frame: from start of treatment to the last glucose measurement under treatment
3 secondary outcomes
Hypoglycemias
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 5 Feb 2010.
- Background: PubMed 18661120Cordingley JJ, Vlasselaers D, Dormand NC, Wouters PJ, Squire SD, Chassin LJ, Wilinska ME, Morgan CJ, Hovorka R, Van den Berghe G. Intensive insulin therapy: enhanced Model Predictive Control algorithm versus standard care. Intensive Care Med. 2009 Jan;35(1):123-8. doi: 10.1007/s00134-008-1236-z. Epub 2008 Jul 26.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
Jeremy Cordingley, Dr. principal investigator
Royal Brompton & Harefield NHS Foundation Trust
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 United Kingdom.
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 4 inclusion and 7 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 5 Feb 2010. 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 United Kingdom. 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 80-150 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 NCT00882427, which also lists 1 linked publication.
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 5 Feb 2010.