DiabetesPhase 3CABGNCT01361594
Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery
A Phase 3 study testing Regular insulin (intensive treatment) and Regular Insulin (conventional treatment) in people with Diabetes, run by Emory University at 1 site in United States.
Trial summary
High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are associated with increased risk of hospital complications. Blood sugar control with intravenous insulin may prevent such hospital complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Regular insulin (intensive treatment) and Regular Insulin (conventional treatment)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2013
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between the ages of 18 and 80 years undergoing CABG +/- valve surgery.
- Post surgical hyperglycemia (BG > 140 mg/dl).
- Patients with and without a history of type 2 diabetes
Who cannot join
- Patients requiring combination CABG with additional procedures such aorta replacement.
- Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or GFR < 30 ml/min) or clinically significant hepatic failure.
- Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
- Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
- Patients or next-to-kin with mental condition rendering the subject or family member unable to understand the nature, scope, and possible consequences of the study.
- Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
Trial locations and contacts
1 site in 1 country.
About this study
High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are associated with increased risk of hospital complications. Blood sugar control with intravenous insulin may prevent such hospital complications. Many patients undergoing cardiac bypass surgery (CABG) develop high blood sugars and require insulin therapy (shortly before or after surgery). It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. Accordingly, this research study aims to determine optimal blood glucose levels during the in patients undergoing cardiac bypass surgery. Patients will be divided in two groups. The intensive insulin group will be maintained at blood glucose between 100-140 mg/dl and the conventional treatment group at a glucose level between 140-180 mg/dl. The insulins to be used in this trial (lantus, aspart and regular insulin) are approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration). A total of 326 patients with high blood glucose after cardiac bypass surgery will be recruited in this study. Patients will be recruited at Emory University Hospital, Emory Midtown Hospital and Grady Memorial Hospital.
Read the detailed description
Several prospective cohort studies as well as randomized clinical trials (RCT) in cardiac surgery patients have shown that intensified insulin therapy (target BG: 110-140 mg/dl) results in a reduction in short- and long-term mortality compared with conventionally treated patients. The results of recent international trials in critically ill patients; however, have failed to show a significant improvement in mortality or have even shown increased mortality risk as well as increased number of hypoglycemic events with intensive compared to less intensive glycemic control. Based on the results of these ICU trials, new ADA and AACE guidelines recommended a glycemic target between 140 and 180 mg/dl in the ICU including cardiac surgery patients. There is concern that such high BG targets might increase the risk of hospital complications in cardiac surgical patients in whom intensive glucose control has consistently reduced infections, length of hospital stay, resource utilization, and cardiac-related mortality. The overall objective of this proposal is to conduct the first prospective RCT to determine the optimal BG target during the perioperative period in hyperglycemic subjects who undergo CABG in the United States. Subjects will be randomized to undergo intensive insulin therapy adjusted to maintain a BG between 100 mg/dl and 140 mg/dl or to a conventional glucose control with a target BG between 141 mg/dl and 200 mg/dl in the ICU. The central hypothesis of this proposal is that intensive insulin management will reduce perioperative complications compared to a conventional BG control in cardiac surgery patients.
- Conditions
- Diabetes
- Being tested
- Regular insulin (intensive treatment), Regular Insulin (conventional treatment)
- Keywords
- Diabetes, Coronary Artery Bypass Surgery, Glycemic control, Insulin infusion
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular insulin (intensive treatment)Other
Titration of the IV insulin rate for glucose goal 100-140 mg/dL
Regular Insulin (conventional treatment)Other
Titration of the IV insulin rate for glucose goal 141-180 mg/dl
| Study group | Role | What they receive |
|---|---|---|
| Intensive insulin treatment | Active comparator | Intensive insulin treatment (BG target: 100-140 mg/dL) Receives: Other: Regular insulin (intensive treatment) |
| Conventional insulin treatment | Active comparator | Conventional insulin treatment (BG target: 141-180 mg/dl) Receives: Other: Regular Insulin (conventional treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects That Were Diagnosed for Peri-operative Complications
Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization
Measured: Within 6 months of hospitalization
Hospital Mortality
Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.
Measured: average 1 month during the hospitalization
Secondary outcomes (17)
Glycemic Control
- Hyperglycemic events (BG > 200 mg/dL) in ICU and non-ICU
- Hypoglycemic events (BG < 70 mg/dl; severe hypoglycemia (BG < 40 mg/dl).
Measured: average 1 month during the hospitalization
Major Cardiovascular Events
- Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).
- Congestive heart failure
- Cardiac arrhythmias: malignant arrhythmia
Measured: average 1 month during the hospitalization
Acute Renal Failure
new-onset abnormal renal function: serum creatinine > 2.0 mg/dL or an increment level > 50% from baseline
Measured: average 1 month during the hospitalization
Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.
Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg.
Measured: average 1 month during the hospitalization
ICU and Hospital Length of Stay, and ICU Readmissions
ICU and hospital length of stay, and ICU readmissions
Measured: average 1 month during the hospitalization
Surgical Wound Infection
superficial and deep sternal wound infection
Measured: average 1 month during the hospitalization
Pneumonia (CDC Criteria)
Pneumonia (CDC criteria)
Measured: average 1 month during the hospitalization
Cerebrovascular Events
permanent stroke and reversible ischemic neurologic deficit.
Measured: average 1 month during the hospitalization
Duration of Ventilatory Support and ICU Readmission
Duration of ventilatory support and ICU readmission
Measured: average 1 month during the hospitalization
Thirty Day Mortality
Thirty day mortality
Measured: within 30 days of discharge
Number of Hospital Readmissions and Emergency Room Visits
Number of hospital readmissions and emergency room visits
Measured: Within 30 days after discharge
Incidence of Organ Failures Assessed by the Daily SOFA Score
Incidence of organ failures assessed by the daily SOFA score
Measured: average 1 month during the hospitalization
Measures of Inflammation
Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers
Measured: average 1 month during the hospitalization
Major Cardiovascular Events
- Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).
- Congestive heart failure
- Cardiac arrhythmias: malignant arrhythmia
Measured: within 3 months after discharge
Surgical Wound Infection
Superficial and deep sternal wound infection
Measured: within 3 months after discharge
Pneumonia (CDC Criteria)
Pneumonia (CDC criteria)
Measured: Within 3 months after discharge
Cerebrovascular Events
permanent stroke and reversible ischemic neurologic deficit
Measured: within 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2013
- Study completionDec 2013
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.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo E Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361594
- Sponsor's protocol ID
- IRB00048356
- Other IDs
- 00048356-2010
- Acronym
- CABG
- Status last verified
- Dec 2014
- First submitted
- 3 Feb 2011
- Last updated
- 31 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT01361594
- Acronym / sponsor ID
- CABG / IRB00048356
- Conditions
- Diabetes
- Keywords
- Diabetes, Coronary Artery Bypass Surgery, Glycemic control, Insulin infusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jun 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 May 2011 (estimated)
- Results
- Posted 31 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are associated with increased risk of hospital complications. Blood sugar control with intravenous insulin may prevent such hospital complications. Many patients undergoing cardiac bypass surgery (CABG) develop high blood sugars and require insulin therapy (shortly before or after surgery). It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. Accordingly, this research study aims to determine optimal blood glucose levels during the in patients undergoing cardiac bypass surgery. Patients will be divided in two groups. The intensive insulin group will be maintained at blood glucose between 100-140 mg/dl and the conventional treatment group at a glucose level between 140-180 mg/dl. The insulins to be used in this trial (lantus, aspart and regular insulin) are approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration). A total of 326 patients with high blood glucose after cardiac bypass surgery will be recruited in this study. Patients will be recruited at Emory University Hospital, Emory Midtown Hospital and Grady Memorial Hospital.
Detailed description
Several prospective cohort studies as well as randomized clinical trials (RCT) in cardiac surgery patients have shown that intensified insulin therapy (target BG: 110-140 mg/dl) results in a reduction in short- and long-term mortality compared with conventionally treated patients. The results of recent international trials in critically ill patients; however, have failed to show a significant improvement in mortality or have even shown increased mortality risk as well as increased number of hypoglycemic events with intensive compared to less intensive glycemic control. Based on the results of these ICU trials, new ADA and AACE guidelines recommended a glycemic target between 140 and 180 mg/dl in the ICU including cardiac surgery patients. There is concern that such high BG targets might increase the risk of hospital complications in cardiac surgical patients in whom intensive glucose control has consistently reduced infections, length of hospital stay, resource utilization, and cardiac-related mortality. The overall objective of this proposal is to conduct the first prospective RCT to determine the optimal BG target during the perioperative period in hyperglycemic subjects who undergo CABG in the United States. Subjects will be randomized to undergo intensive insulin therapy adjusted to maintain a BG between 100 mg/dl and 140 mg/dl or to a conventional glucose control with a target BG between 141 mg/dl and 200 mg/dl in the ICU. The central hypothesis of this proposal is that intensive insulin management will reduce perioperative complications compared to a conventional BG control in cardiac surgery patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive insulin treatment | Active comparator | Other: Regular insulin (intensive treatment)Intensive insulin treatment (BG target: 100-140 mg/dL) |
| Conventional insulin treatment | Active comparator | Other: Regular Insulin (conventional treatment)Conventional insulin treatment (BG target: 141-180 mg/dl) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females between the ages of 18 and 80 years undergoing CABG +/- valve surgery.
- Post surgical hyperglycemia (BG > 140 mg/dl).
- Patients with and without a history of type 2 diabetes
Key exclusion criteria (6 listed)
- Patients requiring combination CABG with additional procedures such aorta replacement.
- Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or GFR < 30 ml/min) or clinically significant hepatic failure.
- Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
- Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
- Patients or next-to-kin with mental condition rendering the subject or family member unable to understand the nature, scope, and possible consequences of the study.
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 |
|---|---|---|
| Regular insulin (intensive treatment)Titration of the IV insulin rate for glucose goal 100-140 mg/dL | Other | Intensive insulin treatment |
| Regular Insulin (conventional treatment)Titration of the IV insulin rate for glucose goal 141-180 mg/dl | Other | Conventional insulin treatment |
Primary outcome
Number of Subjects That Were Diagnosed for Peri-operative Complications
Time frame: Within 6 months of hospitalization
Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization
Hospital Mortality
Time frame: average 1 month during the hospitalization
Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.
17 secondary outcomes
Glycemic Control
Time frame: average 1 month during the hospitalization
Major Cardiovascular Events
Time frame: average 1 month during the hospitalization
Acute Renal Failure
Time frame: average 1 month during the hospitalization
Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.
Time frame: average 1 month during the hospitalization
ICU and Hospital Length of Stay, and ICU Readmissions
Time frame: average 1 month during the hospitalization
Surgical Wound Infection
Time frame: average 1 month during the hospitalization
Pneumonia (CDC Criteria)
Time frame: average 1 month during the hospitalization
Cerebrovascular Events
Time frame: average 1 month during the hospitalization
Duration of Ventilatory Support and ICU Readmission
Time frame: average 1 month during the hospitalization
Thirty Day Mortality
Time frame: within 30 days of discharge
Number of Hospital Readmissions and Emergency Room Visits
Time frame: Within 30 days after discharge
Incidence of Organ Failures Assessed by the Daily SOFA Score
Time frame: average 1 month during the hospitalization
Measures of Inflammation
Time frame: average 1 month during the hospitalization
Major Cardiovascular Events
Time frame: within 3 months after discharge
Surgical Wound Infection
Time frame: within 3 months after discharge
Pneumonia (CDC Criteria)
Time frame: Within 3 months after discharge
Cerebrovascular Events
Time frame: within 3 months after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Guillermo E Umpierrez, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Regular insulin (intensive treatment) and Regular Insulin (conventional treatment) in people with Diabetes, run by Emory University at 1 site in United States.
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 6 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 31 Dec 2014. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2014). 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?
Number of Subjects That Were Diagnosed for Peri-operative Complications (time frame: Within 6 months of hospitalization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2014.