Outcomes With Tight Control of Hyperglycemia in Cardiac Surgery Patients

Phase 3 Completed 400 enrolled Mayo Clinic Novo Nordisk A/S · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Patients with or without diabetes may have high blood sugar levels due to stress response of the body during heart surgery. This study is being done to determine if maintaining normal blood sugar levels during open-heart surgery by using intravenous insulin results in a lesser incidence of death, wound infections in the chest, disturbances of heart rhythm, kidney failure, stroke and prolonged time on the breathing machine (artificial ventilation) within 30 days after surgery.

Timeline

Start: 2004-07
Primary completion: 2005-05
Completion: 2005-05

Outcome

Missed primary endpoint

paper CONCLUSIONS: Intensive insulin therapy during cardiac surgery does not reduce perioperative death or morbidity. PMID 17310047 ↗

paper Eighty two of 185 patients (44%) in the intensive treatment group and 86 of 186 patients (46%) in the conventional treatment group had an event (risk ratio, 1.0 [CI, 0.8 to 1.2]). PMID 17310047 ↗

Publications

Gandhi GY, Nuttall GA, Abel MD, Mullany CJ, Schaff HV, O'Brien PC, Johnson MG, Williams AR, Cutshall SM, Mundy LM, Rizza RA, McMahon MM. Intensive intraoperative insulin therapy versus conventional glucose management during cardiac surgery: a randomized trial. Ann Intern Med. 2007 Feb 20;146(4):233-43. doi: 10.7326/0003-4819-146-4-200702200-00002.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin	Protein / enzyme biologic	—	Intravenous