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NCT01361594 · ClinicalTrials.gov registry record · Phase 3
Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery
A Phase 3 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 3
- Development phase
- 338
- Enrollment target
NCT01361594: Completed Phase 3 study, sponsored by Emory University.
NCT01361594 is a Phase 3 study that has completed, run by Emory University. The registered enrollment target is 338 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01361594, a Phase 3 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 338 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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
Interventions
- OTHER Regular insulin (intensive treatment)
- OTHER Regular Insulin (conventional treatment)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
What the finished NCT01361594 record still lists
NCT01361594 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Regular insulin (intensive treatment) is the first listed.
NCT01361594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01361594 about?
NCT01361594 is a clinical study titled "Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery". 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 ...
What is the current status of trial NCT01361594?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 338 participants. The study started on 2011-06. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01361594?
The interventions under investigation include: Regular insulin (intensive treatment) (OTHER), Regular Insulin (conventional treatment) (OTHER).
Who is sponsoring clinical trial NCT01361594?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01361594's enrollment target sits among peer trials
338 1057th of 2000 higher than 942 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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