NCT01398722

Effect of Intensive Insulin Therapy on Clinical Prognosis of Infants Undergoing Cardiac Surgery

Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

The investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery.

Detailed description

Previous studies showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical and medical intensive care patients. Blood sugar control with intravenous insulin may improve prognosis of patients undergoing cardiac surgery. It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. So far, most of researches have focused on adult patients but little on infants. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of infants undergoing cardiac surgery. On admission, patients will be randomly assigned to either strict normalization of blood glucose ( 110-150 mg/dl) with intensive insulin therapy or the conventional approach, in which blood glucose levels are maintained between 150 and 180 mg/dl.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
OTHER	Intensive insulin therapy	Titration of the IV insulin rate for glucose goal 110-150 mg/dL
OTHER	Conventional insulin therapy	Titration of the IV insulin rate for glucose goal 150-180 mg/dl

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-07-20
• Last updated: 2011-07-20

Locations

1 site across 1 country: China