Critically Ill PatientsNCT00460252
Tight Glycemic Control by eMPC Algorithm in Medical ICU Patients.
A study testing insulin titration applying a computer algorithm in people with Critically Ill Patients and Mechanical Ventilation, run by Medical University of Graz at 1 site in Austria.
Trial summary
This is an open mono-centre randomised controlled trial performed at the Medical University Graz including a treatment visit (V1). In the treatment visit (V1) after admittance to the ICU arterial blood glucose values will be monitored and either the software-algorithm eMPC will be used to adjust the infusion rate of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critically Ill Patients, Mechanical Ventilation, Hyperglycemia
- What is being tested?
- insulin titration applying a computer algorithm
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- May 2006to Nov 2006
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation
- Increased blood glucose levels during ICU care (> 110 mg/dL; > 6.1 mM) or patient on current insulin treatment.
- Age of patients in the range from 18 to 90 years.
Who cannot join
- Known or suspected allergy against insulin.
- Any disease or condition which the Investigator or the treating physician feels would interfere with the trial or the safety of the patient.
- Patients participating in another study.
- Moribund patients likely to die in the next 24 hours.
- Disabled patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Mono-Centre Randomised Controlled Trial to Investigate the Feasibility of Blood Glucose Control With the Software-Algorithm eMPC (Enhanced Model Predictive Control) Via the Arterial-Intravenous Route in Patients at the Medical Intensive Care Unit.
This is an open mono-centre randomised controlled trial performed at the Medical University Graz including a treatment visit (V1). In the treatment visit (V1) after admittance to the ICU arterial blood glucose values will be monitored and either the software-algorithm eMPC will be used to adjust the infusion rate of intravenously administered human soluble insulin to normalise arterial blood glucose or routine treatment will be used to establish tight glycaemic control. The treatment visit will last for 72 hours.
The primary hypothesis of the study is that blood glucose control by the eMPC algorithm is not inferior compared to the implemented routine protocol.
Read the detailed description
Hyperglycaemia is commonly found in critically ill patients. The stress of critical illness induces glucose counterregulatory hormones and a number of alterations in carbohydrate metabolism, including increased peripheral glucose demands, enhanced hepatic glucose production, insulin resistance and relative insulin deficiency. Moreover, clinical interventions, such as corticoids, vasopressors, and enteral or parenteral nutrition, further predispose these patients to elevated blood glucose levels. In patients in intensive care as well as in general hospital settings patients with hyperglycemia have higher mortality rates. Recent studies demonstrated that tight blood glucose control in ICU patients results in a significant better outcome for the patients.
Based on this emerging clinical evidence, there are increasing efforts world-wide 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 and such increased work demands may not be readily accepted by a busy ICU nursing staff.
The development of a closed loop control system that automatically infuses insulin on the basis of glucose measurements could permit strict glycaemic control and improve clinical outcome without increasing workload of the ICU nursing staff. The EU founded project CLINICIP (Closed Loop Infusion in Critically ill patients) aims to develop a low-risk monitoring and control system which allows maintaining metabolic control in intensive care units. As a first step a local bedside semi-closed system will be developed. Based on arterial spot measurement, an adaptive control algorithm will generate advice and thus represent a decision supporting system for the ICU nursing staff. This control algorithm was adapted for patients in the ICU. The first study using this algorithm was performed at the Medical University Hospital in Graz. In all six patients, who were included in this feasibility trial, blood glucose levels could be normalised and maintained in the narrow target range for up to 24 hours without a single hypoglycaemic episode. Subsequently, the algorithm was tested in a multicentric randomized controlled trial setting and showed superiority by means of a reduced number of hypoglycaemic events and a higher percentage of glucose values within the target range as compared to routine care glucose management protocols. In this study it was a fact that the hourly sampling frequency in the algorithm group has positively influenced the outcome in the algorithm group. Therefore in an enhanced version of the algorithm (eMPC) the sampling interval is expanded up to 240 min.
The purpose of this study is to evaluate the feasibility of this enhanced model predictive control algorithm for glycaemic control in critically ill patients compared to routine treatment.
- Being tested
- insulin titration applying a computer algorithm
- Keywords
- algorithm, insulin, hyperglycemia, tight glycemic control, intensive care, adults
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin titration applying a computer algorithmProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperglycemic Index
Secondary outcomes (4)
Number of hypoglycaemic episodes (BG < 40 mg/dl (< 2.2mM) [10] )
Mean glucose
Sampling interval
Insulin need
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startMay 2006
- Study completionNov 2006
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 Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Investigators
- Thomas R Pieber, MD., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460252
- Sponsor's protocol ID
- CM4
- Status last verified
- Apr 2007
- First submitted
- 12 Apr 2007
- Last updated
- 13 Apr 2007
- 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 16443872
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Mono-Centre Randomised Controlled Trial to Investigate the Feasibility of Blood Glucose Control With the Software-Algorithm eMPC (Enhanced Model Predictive Control) Via the Arterial-Intravenous Route in Patients at the Medical Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT00460252
- Acronym / sponsor ID
- CM4
- Keywords
- algorithm, insulin, hyperglycemia, tight glycemic control, intensive care, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 13 Apr 2007 (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.
This is an open mono-centre randomised controlled trial performed at the Medical University Graz including a treatment visit (V1). In the treatment visit (V1) after admittance to the ICU arterial blood glucose values will be monitored and either the software-algorithm eMPC will be used to adjust the infusion rate of intravenously administered human soluble insulin to normalise arterial blood glucose or routine treatment will be used to establish tight glycaemic control. The treatment visit will last for 72 hours.
The primary hypothesis of the study is that blood glucose control by the eMPC algorithm is not inferior compared to the implemented routine protocol.
Detailed description
Hyperglycaemia is commonly found in critically ill patients. The stress of critical illness induces glucose counterregulatory hormones and a number of alterations in carbohydrate metabolism, including increased peripheral glucose demands, enhanced hepatic glucose production, insulin resistance and relative insulin deficiency. Moreover, clinical interventions, such as corticoids, vasopressors, and enteral or parenteral nutrition, further predispose these patients to elevated blood glucose levels. In patients in intensive care as well as in general hospital settings patients with hyperglycemia have higher mortality rates. Recent studies demonstrated that tight blood glucose control in ICU patients results in a significant better outcome for the patients.
Based on this emerging clinical evidence, there are increasing efforts world-wide 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 and such increased work demands may not be readily accepted by a busy ICU nursing staff.
The development of a closed loop control system that automatically infuses insulin on the basis of glucose measurements could permit strict glycaemic control and improve clinical outcome without increasing workload of the ICU nursing staff. The EU founded project CLINICIP (Closed Loop Infusion in Critically ill patients) aims to develop a low-risk monitoring and control system which allows maintaining metabolic control in intensive care units. As a first step a local bedside semi-closed system will be developed. Based on arterial spot measurement, an adaptive control algorithm will generate advice and thus represent a decision supporting system for the ICU nursing staff. This control algorithm was adapted for patients in the ICU. The first study using this algorithm was performed at the Medical University Hospital in Graz. In all six patients, who were included in this feasibility trial, blood glucose levels could be normalised and maintained in the narrow target range for up to 24 hours without a single hypoglycaemic episode. Subsequently, the algorithm was tested in a multicentric randomized controlled trial setting and showed superiority by means of a reduced number of hypoglycaemic events and a higher percentage of glucose values within the target range as compared to routine care glucose management protocols. In this study it was a fact that the hourly sampling frequency in the algorithm group has positively influenced the outcome in the algorithm group. Therefore in an enhanced version of the algorithm (eMPC) the sampling interval is expanded up to 240 min.
The purpose of this study is to evaluate the feasibility of this enhanced model predictive control algorithm for glycaemic control in critically ill patients compared to routine treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mechanical ventilation
- Increased blood glucose levels during ICU care (> 110 mg/dL; > 6.1 mM) or patient on current insulin treatment.
- Age of patients in the range from 18 to 90 years.
Key exclusion criteria (5 listed)
- Known or suspected allergy against insulin.
- Any disease or condition which the Investigator or the treating physician feels would interfere with the trial or the safety of the patient.
- Patients participating in another study.
- Moribund patients likely to die in the next 24 hours.
- Disabled patients
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 titration applying a computer algorithm | Procedure or surgery | – |
Primary outcome
Hyperglycemic Index
4 secondary outcomes
Number of hypoglycaemic episodes (BG < 40 mg/dl (< 2.2mM) [10] )
Mean glucose
Sampling interval
Insulin need
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 13 Apr 2007.
- 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.
Related trials for Critically Ill Patients
Recruiting
KInetics of Procalcitonin to Reduce Unnecessary aNtibiotic Use - Comparing Procalcitonin Kinetics-guided and Absolute Procalcitonin Value-guided Antibiotic Initiation in Reducing Unnecessary Antibiotic Use in Critically Ill Patients
Infection, Sepsis
Not yet recruitingObservational study
Capillary Refill Time Variation to Predict Oxygen Comsumption Variation After FLuid Challenge (CARTOFL)
Critically Ill Patients, Circulatory Shock
RecruitingPhase 4
CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime/AVIbactam in Critically Ill Patients
Severe Infection
Not yet recruitingObservational study
Lactate/Albumin Ratio and Mortality in Respiratory Failure
Acute Respiratory Failure, Critical Illness
RecruitingObservational study
Respiratory Physiotherapy and Inflammatory Biomarkers in Critically Ill Patients With Pneumonia
Pneumonia, 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.
Thomas R Pieber, MD. 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 testing insulin titration applying a computer algorithm in people with Critically Ill Patients and Mechanical Ventilation, run by Medical University of Graz 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 5 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 13 Apr 2007. 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?
Hyperglycemic Index. 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 NCT00460252, 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 13 Apr 2007.