Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Emory University. The registered enrollment target is 338 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01361594
The ClinicalTrials.gov registry entry for NCT01361594 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 338 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Regular insulin (intensive treatment) is the first listed.
NCT01361594 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.