HyperglycemiaNCT01886365
Computerized Tight Glycemic Control in Cardiac Surgery
A study testing Conventional therapy with a fixed insulin dosing scheme in people with Hyperglycemia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The debate about tight glycemic control (TGC) in the operating room and on the intensive care unit is ongoing, especially in cardio-surgical patients treated with blood cardioplegia, due to high blood glucose levels during operations and subsequent high rates of sternal wound infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Conventional therapy with a fixed insulin dosing scheme
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Oct 2012
- 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
- patients over 18 scheduled for elective cardiac surgery with the use of cardiopulmonary bypass and blood cardioplegia
Who cannot join
- under 18 years of age, or if patients had a premedical history of steroid therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: Perioperative Glycemic Control With a Computerized Algorithm vs. Conventional Glycemic Control in Cardio-surgical Patients Undergoing Cardiopulmonary Bypass With Blood Cardioplegia
The debate about tight glycemic control (TGC) in the operating room and on the intensive care unit is ongoing, especially in cardio-surgical patients treated with blood cardioplegia, due to high blood glucose levels during operations and subsequent high rates of sternal wound infections. We showed in a feasibility study that early computer based insulin therapy starting in the operating room is a safe therapy that allows to better warrant normoglycemia in patients undergoing major cardiac surgery with the use of blood cardioplegia.
Read the detailed description
Patients are enrolled and randomized into 3 groups. Start of therapy is determined as the beginning of cardiopulmonary bypass. Group A: Therapy with computer-based algorithm and measurement of blood glucose every 30 min. Group B: Measurement of blood glucose every 15 min using the identical computer-based algorithm. Group C: Conventional therapy using a fixed insulin dosing scheme. End of therapy is defined as discharge from ICU.
- Conditions
- Hyperglycemia
- Being tested
- Space GlucoseControl System, B. Braun, Melsungen, Germany, Conventional therapy with a fixed insulin dosing scheme
- Keywords
- Computer based glycemic control, insulin, blood glucose
- 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.
Space GlucoseControl System, B. Braun, Melsungen, GermanyDevice
Computerized algorithmic application of insulin
Conventional therapy with a fixed insulin dosing schemeOther
Routine care
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | With start of the cardiopulmonary bypass, computerized algorithmic application of insulin was performed with a dedicated computerized syringe pump system (Space GlucoseControl System, B. Braun, Germany). The targeted corridor for blood glucose was determined with 80 - 150 mg/dl. During surgery, blood glucose was measured every 30 min, and on the ICU every 2 hours. TGC management was continued until ICU discharge. Receives: Device: Space GlucoseControl System, B. Braun, Melsungen, Germany |
| Group B | Active comparator | Corresponding computerized algorithmic application of insulin management was used as for group A. However, only the interval of blood glucose measurement during surgery was adjusted to 15 minutes. Receives: Device: Space GlucoseControl System, B. Braun, Melsungen, Germany |
| Group C | Other | With start of the cardiopulmonary bypass conventional therapy with a fixed insulin dosing scheme was initiated. If blood glucose was > 150 mg/dl, manual insulin therapy was started following a fixed insulin dosing scheme. Measurements of blood glucose were performed during surgery every 30 minutes, and on the ICU every 2 hours until discharge (Routine Care). Receives: Other: Conventional therapy with a fixed insulin dosing scheme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time within a blood glucose corridor of 80 - 150 mg/dl
The primary endpoint was defined as the time within a given blood glucose corridor from 80 - 150 mg/dl during therapy
Measured: From start of cardiopulmonary bypass during surgery until discharge from ICU, which is approximately after 48 -72 hrs.
Secondary outcomes (1)
Hypoglycemic events
Secondary endpoints were the number of hypoglycemic events defined as blood glucose levels under 80 mg/dl
Measured: From beginning of cardiopulmonary bypass during surgery until discharge from the ICU, which is approximately after 48-72 hrs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionOct 2012
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 HyperglycemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Responsible party
- Principal investigator, Prof. Dr. med. Daniel Reuter, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Daniel A Reuter, Professor, Principal investigator, University Medical Center Hamburg-Eppendorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886365
- Sponsor's protocol ID
- PV3388
- Status last verified
- Jun 2013
- First submitted
- 12 Jun 2013
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
PubMed 37526194Punke MA, Goepfert MS, Kluge S, Reichenspurner H, Goetz AE, Reuter DA. Perioperative glycemic control with a computerized algorithm versus conventional glycemic control in cardiac surgical patients undergoing cardiopulmonary bypass with blood cardioplegia. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1273-7. doi: 10.1053/j.jvca.2014.04.017.
PubMed 25281044
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Glycemic Control With a Computerized Algorithm vs. Conventional Glycemic Control in Cardio-surgical Patients Undergoing Cardiopulmonary Bypass With Blood Cardioplegia
- ClinicalTrials.gov ID
- NCT01886365
- Acronym / sponsor ID
- PV3388
- Conditions
- Hyperglycemia
- Keywords
- Computer based glycemic control, insulin, blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 Jun 2013 (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.
The debate about tight glycemic control (TGC) in the operating room and on the intensive care unit is ongoing, especially in cardio-surgical patients treated with blood cardioplegia, due to high blood glucose levels during operations and subsequent high rates of sternal wound infections. We showed in a feasibility study that early computer based insulin therapy starting in the operating room is a safe therapy that allows to better warrant normoglycemia in patients undergoing major cardiac surgery with the use of blood cardioplegia.
Detailed description
Patients are enrolled and randomized into 3 groups. Start of therapy is determined as the beginning of cardiopulmonary bypass. Group A: Therapy with computer-based algorithm and measurement of blood glucose every 30 min. Group B: Measurement of blood glucose every 15 min using the identical computer-based algorithm. Group C: Conventional therapy using a fixed insulin dosing scheme. End of therapy is defined as discharge from ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Space GlucoseControl System, B. Braun, Melsungen, GermanyWith start of the cardiopulmonary bypass, computerized algorithmic application of insulin was performed with a dedicated computerized syringe pump system (Space GlucoseControl System, B. Braun, Germany). The targeted corridor for blood glucose was determined with 80 - 150 mg/dl. During surgery, blood glucose was measured every 30 min, and on the ICU every 2 hours. TGC management was continued until ICU discharge. |
| Group B | Active comparator | Device: Space GlucoseControl System, B. Braun, Melsungen, GermanyCorresponding computerized algorithmic application of insulin management was used as for group A. However, only the interval of blood glucose measurement during surgery was adjusted to 15 minutes. |
| Group C | Other | Other: Conventional therapy with a fixed insulin dosing schemeWith start of the cardiopulmonary bypass conventional therapy with a fixed insulin dosing scheme was initiated. If blood glucose was > 150 mg/dl, manual insulin therapy was started following a fixed insulin dosing scheme. Measurements of blood glucose were performed during surgery every 30 minutes, and on the ICU every 2 hours until discharge (Routine Care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients over 18 scheduled for elective cardiac surgery with the use of cardiopulmonary bypass and blood cardioplegia
Key exclusion criteria (1 listed)
- under 18 years of age, or if patients had a premedical history of steroid therapy
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 |
|---|---|---|
| Space GlucoseControl System, B. Braun, Melsungen, GermanyComputerized algorithmic application of insulin | Device | Group A, Group B |
| Conventional therapy with a fixed insulin dosing schemeRoutine care | Other | Group C |
Primary outcome
Time within a blood glucose corridor of 80 - 150 mg/dl
Time frame: From start of cardiopulmonary bypass during surgery until discharge from ICU, which is approximately after 48 -72 hrs.
The primary endpoint was defined as the time within a given blood glucose corridor from 80 - 150 mg/dl during therapy
1 secondary outcome
Hypoglycemic events
Time frame: From beginning of cardiopulmonary bypass during surgery until discharge from the ICU, which is approximately after 48-72 hrs.
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 25 Jun 2013.
- Derived from this study: PubMed 37526194Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
- Derived from this study: PubMed 25281044Punke MA, Goepfert MS, Kluge S, Reichenspurner H, Goetz AE, Reuter DA. Perioperative glycemic control with a computerized algorithm versus conventional glycemic control in cardiac surgical patients undergoing cardiopulmonary bypass with blood cardioplegia. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1273-7. doi: 10.1053/j.jvca.2014.04.017.
Related trials for Hyperglycemia
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes
Not yet recruitingEarly Phase 1
Efficacy of the pA1c®HI Postbiotic in Metabolic Regulation in Healthy Individuals With Hyperglycemia
Hyperglycemias, Prediabetes
Active, not recruiting
Insulin Balanced Infusion System
Hyperglycemia, Diabetes
Not yet recruitingObservational study
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
End Stage Kidney Disease (ESKD), Hyperglycaemia
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.
Daniel A Reuter, Professor principal investigator
University Medical Center Hamburg-Eppendorf, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional therapy with a fixed insulin dosing scheme in people with Hyperglycemia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 25 Jun 2013. 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 Germany. 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?
Time within a blood glucose corridor of 80 - 150 mg/dl (time frame: From start of cardiopulmonary bypass during surgery until discharge from ICU, which is approximately after 48 -72 hrs.). 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 NCT01886365, 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 25 Jun 2013.