CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 338 enrolled
Drug / intervention
Regular insulin (intensive treatment) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01361594
NCT01361594Phase 3Completed

Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery

Emory University·interventional·Posted May 27, 2011·Updated Dec 31, 2014

In Brief

A Phase 3 clinical trial evaluating Regular insulin (intensive treatment) and Regular Insulin (conventional treatment) for Diabetes. Completed, enrolled 338 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 27, 2011
Enrollment StartJun 1, 2011
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.1 years ago

Interventions

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