Cardiac SurgeryNCT00524472
Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery
A study testing Hyperinsulinemic-normoglycemic clamp in people with Cardiac Surgery, run by The Cleveland Clinic at 2 sites in 2 countries.
Trial summary
Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood glucose levels intra-operatively. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Hyperinsulinemic-normoglycemic clamp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,439 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2007to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18-90 years old
- Scheduled for cardiac surgery requiring cardiopulmonary bypass
Who cannot join
- Off-pump surgical procedures
- Anticipated deep hypothermic circulatory arrest
- In available, baseline cardiac troponin I (>0.5 ng/L) or troponin T (> 0.1 ng/mL) levels (at RVH or CC, respectively)
- Any contraindications to the proposed interventions
- Active infection, including patients with endocarditis or infected pacemaker leads.
- Any infection requiring long- term antibiotics ( > 14 days)
- kidney disease requiring renal replacement therapy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery
Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood glucose levels intra-operatively. Group B will be administered insulin at the standard of care levels established by the participating institution. Patients will be followed at 10 days, 15 days and one year post-operatively.
Read the detailed description
Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite outcome (one or more) of 30-day postoperative mortality and serious postoperative cardiac, renal, neurologic, and infectious postoperative complications in patients undergoing cardiac surgery.
Our secondary hypothesis is that hyperinsulinemic normoglycemic therapy will reduce length of stay in intensive care unit, atrial dysrhythmias, creatinine elevation, hospital readmission, all-cause and cardiac one-year mortality.
- Conditions
- Cardiac Surgery
- Being tested
- Hyperinsulinemic-normoglycemic clamp, insulin at the standard of care levels
- Keywords
- Hyperinsulinemic glucose control, cardiac surgery, Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic-normoglycemic clampOther
Also called clamp, Hyperinsulinemic
Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.
insulin at the standard of care levelsOther
Also called insulin
Subjects will be administered insulin at the standard of care levels established by the participating institution.
| Study group | Role | What they receive |
|---|---|---|
| Hyperinsulinemic-normoglycemic clamp | Experimental | Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. Receives: Other: Hyperinsulinemic-normoglycemic clamp |
| Insulin at the standard of care levels | Other | Group B will be administered insulin at the standard of care levels established by the participating institution. Receives: Other: insulin at the standard of care levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any Major Morbidity/30-day Mortality
a composite (any versus none) of the following major postoperative complications occurring:
- all-cause postoperative mortality
- failure to wean from cardiopulmonary bypass or postoperative low cardiac index requiring mechanical circulatory support with intraaortic balloon counterpulsation, ventricular assist device, and/or extracorporeal mechanical oxygenation
- serious postoperative infection
- acute postoperative kidney injury requiring renal replacement therapy;
- new postoperative focal or global neurologic deficit.
Measured: within 30 days post surgery
Secondary outcomes (5)
Post Operative Atrial Fibrillation
Evidence suggests that maintaining intra-operative normoglycemia during cardiac surgery while providing exogenous glucose and high-dose insulin may decrease post-operative morbidity or mortality. Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite of serious adverse outcomes in patients undergoing cardiac surgery
Measured: 15 - 30 days post operative
Duration of Hospitalization
Days from date of surgery to hospital discharge
Measured: starting post operative day one to discharge from hospital, on an average of 8 days
Duration of Intensive Care Stay
Hours from date of surgery to discharge from intensive care unit
Measured: ICU stay hours during hospital stay after surgery, on average of 25 hours
All-cause Mortality
All-cause mortality identified during one-year follow-up.
Measured: one year post operative
a Composite of Minor Postoperative Complications
a composite of minor postoperative complications, which includes: a) prolonged mechanical ventilation, b) low cardiac index, c) acute kidney injury, d) prolonged hospitalization, and 3) all-cause hospital readmission within 30 days.
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,439 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andra I Duncan, M.D., Principal investigator, The Cleveland ClinicDaniel I Sessler, M.D., Study director, The Cleveland ClinicThomas Schricker, MD, Principal investigator, Royal Victoria Hospital, Montreal, CanadaGeorge Carvalho, MD, Principal investigator, Royal Victoria Hospital, Montreal, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524472
- Sponsor's protocol ID
- 07-470
- Status last verified
- Feb 2018
- First submitted
- 31 Aug 2007
- Last updated
- 26 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Albacker TB, Carvalho G, Schricker T, Lachapelle K. Myocardial protection during elective coronary artery bypass grafting using high-dose insulin therapy. Ann Thorac Surg. 2007 Dec;84(6):1920-7; discussion 1920-7. doi: 10.1016/j.athoracsur.2007.07.001.
PubMed 18036907Duncan AE, Kateby Kashy B, Sarwar S, Singh A, Stenina-Adognravi O, Christoffersen S, Alfirevic A, Sale S, Yang D, Thomas JD, Gillinov M, Sessler DI. Hyperinsulinemic Normoglycemia Does Not Meaningfully Improve Myocardial Performance during Cardiac Surgery: A Randomized Trial. Anesthesiology. 2015 Aug;123(2):272-87. doi: 10.1097/ALN.0000000000000723.
PubMed 26200180Bellon 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 37526194Schricker T, Sato H, Beaudry T, Codere T, Hatzakorzian R, Pruessner JC. Intraoperative maintenance of normoglycemia with insulin and glucose preserves verbal learning after cardiac surgery. PLoS One. 2014 Jun 18;9(6):e99661. doi: 10.1371/journal.pone.0099661. eCollection 2014.
PubMed 24941010
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00524472
- Acronym / sponsor ID
- 07-470
- Conditions
- Cardiac Surgery
- Keywords
- Hyperinsulinemic glucose control, cardiac surgery, Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,439 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jul 2007 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Posted 26 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood glucose levels intra-operatively. Group B will be administered insulin at the standard of care levels established by the participating institution. Patients will be followed at 10 days, 15 days and one year post-operatively.
Detailed description
Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite outcome (one or more) of 30-day postoperative mortality and serious postoperative cardiac, renal, neurologic, and infectious postoperative complications in patients undergoing cardiac surgery.
Our secondary hypothesis is that hyperinsulinemic normoglycemic therapy will reduce length of stay in intensive care unit, atrial dysrhythmias, creatinine elevation, hospital readmission, all-cause and cardiac one-year mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperinsulinemic-normoglycemic clamp | Experimental | Other: Hyperinsulinemic-normoglycemic clampPatients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. |
| Insulin at the standard of care levels | Other | Other: insulin at the standard of care levelsGroup B will be administered insulin at the standard of care levels established by the participating institution. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-90 years old
- Scheduled for cardiac surgery requiring cardiopulmonary bypass
Key exclusion criteria (7 listed)
- Off-pump surgical procedures
- Anticipated deep hypothermic circulatory arrest
- In available, baseline cardiac troponin I (>0.5 ng/L) or troponin T (> 0.1 ng/mL) levels (at RVH or CC, respectively)
- Any contraindications to the proposed interventions
- Active infection, including patients with endocarditis or infected pacemaker leads.
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 |
|---|---|---|
| Hyperinsulinemic-normoglycemic clampAlso: clamp, HyperinsulinemicPatients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. | Other | Hyperinsulinemic-normoglycemic clamp |
| insulin at the standard of care levelsAlso: insulinSubjects will be administered insulin at the standard of care levels established by the participating institution. | Other | Insulin at the standard of care levels |
Primary outcome
Any Major Morbidity/30-day Mortality
Time frame: within 30 days post surgery
a composite (any versus none) of the following major postoperative complications occurring: 1. all-cause postoperative mortality 2. failure to wean from cardiopulmonary bypass or postoperative low cardiac index requiring mechanical circulatory support with intraaortic balloon counterpulsation, ventricular assist device, and/or extracorporeal mechanical oxygenation 3. serious postoperative infection 4. acute postoperative kidney injury requiring renal replacement therapy; 5. new postoperative focal or global neurologic deficit.
5 secondary outcomes
Post Operative Atrial Fibrillation
Time frame: 15 - 30 days post operative
Duration of Hospitalization
Time frame: starting post operative day one to discharge from hospital, on an average of 8 days
Duration of Intensive Care Stay
Time frame: ICU stay hours during hospital stay after surgery, on average of 25 hours
All-cause Mortality
Time frame: one year post operative
a Composite of Minor Postoperative Complications
Time frame: within 30 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18036907Albacker TB, Carvalho G, Schricker T, Lachapelle K. Myocardial protection during elective coronary artery bypass grafting using high-dose insulin therapy. Ann Thorac Surg. 2007 Dec;84(6):1920-7; discussion 1920-7. doi: 10.1016/j.athoracsur.2007.07.001.
- Results publication: PubMed 26200180Duncan AE, Kateby Kashy B, Sarwar S, Singh A, Stenina-Adognravi O, Christoffersen S, Alfirevic A, Sale S, Yang D, Thomas JD, Gillinov M, Sessler DI. Hyperinsulinemic Normoglycemia Does Not Meaningfully Improve Myocardial Performance during Cardiac Surgery: A Randomized Trial. Anesthesiology. 2015 Aug;123(2):272-87. doi: 10.1097/ALN.0000000000000723.
- 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 24941010Schricker T, Sato H, Beaudry T, Codere T, Hatzakorzian R, Pruessner JC. Intraoperative maintenance of normoglycemia with insulin and glucose preserves verbal learning after cardiac surgery. PLoS One. 2014 Jun 18;9(6):e99661. doi: 10.1371/journal.pone.0099661. eCollection 2014.
- Individual participant dataSharing planned: No
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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.
Andra I Duncan, M.D. principal investigator
The Cleveland Clinic
Daniel I Sessler, M.D. study director
The Cleveland Clinic
Thomas Schricker, MD principal investigator
Royal Victoria Hospital, Montreal, Canada
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperinsulinemic-normoglycemic clamp in people with Cardiac Surgery, run by The Cleveland Clinic at 2 sites in 2 countries.
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 2 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 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 26 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Any Major Morbidity/30-day Mortality (time frame: within 30 days post surgery). 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 NCT00524472, which also lists 4 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 26 Oct 2018.