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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperinsulinemic-normoglycemic clamp | Experimental | 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 levels | Other | Group B will be administered insulin at the standard of care levels established by the participating institution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperinsulinemic-normoglycemic clamp | Other | Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Any Major Morbidity/30-day Mortality | a composite (any versus none) of the following major postoperative complications occurring:
| within 30 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andra I Duncan, M.D. | The Cleveland Clinic | Principal Investigator |
| Daniel I Sessler, M.D. | The Cleveland Clinic | Study Director |
| Thomas Schricker, MD | Royal Victoria Hospital, Montreal, Canada | Principal Investigator |
| George Carvalho, MD | Royal Victoria Hospital, Montreal, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States | ||
| Royal Victoria Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18036907 | Result | 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. | |
| 26200180 | Result | Duncan 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyperinsulinemic-normoglycemic Clamp | Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. Hyperinsulinemic-normoglycemic clamp: Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. |
| FG001 | Insulin at the Standard of Care Levels | Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hyperinsulinemic-normoglycemic Clamp | Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. Hyperinsulinemic-normoglycemic clamp: Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Any Major Morbidity/30-day Mortality | a composite (any versus none) of the following major postoperative complications occurring:
| Posted | Count of Participants | Participants | within 30 days post surgery |
|
One Year Post-opeperative follow-up for All-Cause Mortality; 1 month Post-opeperative follow-up for Serious Adverse Events and Other (Not Including Serious) Adverse Events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyperinsulinemic-normoglycemic Clamp | Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. Hyperinsulinemic-normoglycemic clamp: Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sae | Surgical and medical procedures | Systematic Assessment | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andra Duncan, MD | Cleveland Clinic | 216 445-2372 | DUNCANA@ccf.org |
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| ID | Term |
|---|---|
| D003250 | Constriction |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
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|
| insulin at the standard of care levels | Other | Subjects will be administered insulin at the standard of care levels established by the participating institution. |
|
|
| 15 - 30 days post operative |
| Duration of Hospitalization | Days from date of surgery to hospital discharge | 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 | 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. | 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. | within 30 days after surgery |
| Montreal |
| Quebec |
| H3A 1A1 |
| Canada |
| 37526194 | Derived | 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. |
| 24941010 | Derived | Schricker 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. |
| Insulin at the Standard of Care Levels |
Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Insulin at the Standard of Care Levels | Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution. |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 15 - 30 days post operative |
|
|
|
|
| Secondary | Duration of Hospitalization | Days from date of surgery to hospital discharge | Posted | Median | 95% Confidence Interval | days | starting post operative day one to discharge from hospital, on an average of 8 days |
|
|
|
|
| Secondary | Duration of Intensive Care Stay | Hours from date of surgery to discharge from intensive care unit | Posted | Median | 95% Confidence Interval | hours | ICU stay hours during hospital stay after surgery, on average of 25 hours |
|
|
|
|
| Secondary | All-cause Mortality | All-cause mortality identified during one-year follow-up. | Posted | Count of Participants | Participants | one year post operative |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | within 30 days after surgery |
|
|
|
|
| 32 |
| 709 |
| 18 |
| 709 |
| 0 |
| 709 |
| EG001 | Insulin at the Standard of Care Levels | Group B will be administered insulin at the standard of care levels established by the participating institution. insulin at the standard of care levels: Subjects will be administered insulin at the standard of care levels established by the participating institution. | 22 | 730 | 27 | 730 | 0 | 730 |
|
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| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |