HyperglycemiaNCT00764712
Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
A study testing insulin in people with Hyperglycemia, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
A randomized trial to compare three insulin-titration protocols for tight glycemic control in surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath) protocol, and an enhanced model predictive control algorithm (eMPC) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- insulin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- Feb 2008to Apr 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients admitted to the postoperative ICU after elective cardiac surgery
Who cannot join
- insulin allergy
Trial locations and contacts
1 site in 1 country.
About this study
A randomized trial to compare three insulin-titration protocols for tight glycemic control in surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath) protocol, and an enhanced model predictive control algorithm (eMPC)
Read the detailed description
120 consecutive post-cardiac surgery patients randomized to the three protocols with a target glycemia range from 4.4 to 6.1 mmol/l. Intravenous insulin was administered continuously or in combination with insulin boluses (Matias protocol). Blood glucose was measured in 1-4 hour intervals as requested by protocols.
- Conditions
- Hyperglycemia
- Being tested
- insulin
- Keywords
- Tight glycemia control, cardiac surgery patients
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulinDrug
Also called Actrapid HM, Novo Nordisk, Baegsvard, Denmark
Insulin was was administered according to each protocol rules/suggestions into a central venous line as a continuous infusion (Bath and eMPC protocols) or as a combination of a continuous infusion and boluses (Matias protocol). A standard concentration of 50 IU of insulin in 50 ml of 0.9% NaCl was used. In all patients, infusion of 10% glucose solution was initiated upon admission to ICU with glucose dose of 2.5 g/kg of ideal body weight (height in centimetres minus 100) per hour and lasted for 18 hours, when normal oral food intake was started. In ventilated patients, the glucose infusion lasted for 48 hours, and then standard enteral nutrition was initiated.
| Study group | Role | What they receive |
|---|---|---|
| Matias protocol | Active comparator | A protocol based on the absolute glucose value - Matias protocol (Matias) Receives: Drug: insulin |
| Bath protocol | Active comparator | A protocol based on the relative glucose change - Bath protocol (Bath) Receives: Drug: insulin |
| eMPC | Active comparator | a computer-based model predictive control algorithm with variable sampling rate (eMPC) Receives: Drug: insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of different TGC management protocols
Measured: ICU stay
Secondary outcomes (1)
The safety with respect to hypoglycemia
Measured: ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2008
- Study completionApr 2008
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 HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Blaha, Charles University, Czech Republic
- Investigators
- Jan Blaha, MD, Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764712
- Sponsor's protocol ID
- POINT-protocols
- Other IDs
- GAUK no. 44407
- Status last verified
- Mar 2012
- First submitted
- 1 Oct 2008
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Blaha J, Kopecky P, Kotulak T, Kunstyr J, Matias M, Rubes D, Dobias M, Romaniv S, Kubatova J, Porizka M et al: Blood glucose control in cardiac surgery patients: a comparative study of different insulin protocols. Journal of Cardiothoracic and Vascular Anesthesia 2008, 22(S3):S23.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT00764712
- Acronym / sponsor ID
- POINT-protocols
- Conditions
- Hyperglycemia
- Keywords
- Tight glycemia control, cardiac surgery patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 2 Oct 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.
A randomized trial to compare three insulin-titration protocols for tight glycemic control in surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath) protocol, and an enhanced model predictive control algorithm (eMPC)
Detailed description
120 consecutive post-cardiac surgery patients randomized to the three protocols with a target glycemia range from 4.4 to 6.1 mmol/l. Intravenous insulin was administered continuously or in combination with insulin boluses (Matias protocol). Blood glucose was measured in 1-4 hour intervals as requested by protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Matias protocol | Active comparator | Drug: insulinA protocol based on the absolute glucose value - Matias protocol (Matias) |
| Bath protocol | Active comparator | Drug: insulinA protocol based on the relative glucose change - Bath protocol (Bath) |
| eMPC | Active comparator | Drug: insulina computer-based model predictive control algorithm with variable sampling rate (eMPC) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients admitted to the postoperative ICU after elective cardiac surgery
Key exclusion criteria (1 listed)
- insulin allergy
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 |
|---|---|---|
| insulinAlso: Actrapid HM, Novo Nordisk, Baegsvard, DenmarkInsulin was was administered according to each protocol rules/suggestions into a central venous line as a continuous infusion (Bath and eMPC protocols) or as a combination of a continuous infusion and boluses (Matias protocol). A standard concentration of 50 IU of insulin in 50 ml of 0.9% NaCl was used. In all patients, infusion of 10% glucose solution was initiated upon admission to ICU with glucose dose of 2.5 g/kg of ideal body weight (height in centimetres minus 100) per hour and lasted for 18 hours, when normal oral food intake was started. In ventilated patients, the glucose infusion lasted for 48 hours, and then standard enteral nutrition was initiated. | Drug | Bath protocol, Matias protocol, eMPC |
Primary outcome
The effectiveness of different TGC management protocols
Time frame: ICU stay
1 secondary outcome
The safety with respect to hypoglycemia
Time frame: ICU stay
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 12 Mar 2012.
- Results publicationBlaha J, Kopecky P, Kotulak T, Kunstyr J, Matias M, Rubes D, Dobias M, Romaniv S, Kubatova J, Porizka M et al: Blood glucose control in cardiac surgery patients: a comparative study of different insulin protocols. Journal of Cardiothoracic and Vascular Anesthesia 2008, 22(S3):S23.
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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.
Jan Blaha, MD principal investigator
Charles University, Czech Republic
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 in people with Hyperglycemia, run by Charles University, Czech Republic at 1 site in Czechia.
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 12 Mar 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 Czechia. 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?
The effectiveness of different TGC management protocols (time frame: ICU stay). 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 NCT00764712, 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 12 Mar 2012; AzTrials last refreshed its copy on 6 Nov 2026.