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

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2

Conditions: Cardiac Surgery

Treatments: Other: Conventional insulin therapy; Other: Intensive insulin therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01398722

Guch-012

Details and patient eligibility

About

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

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: Under 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants underwent cardiac surgery with cardiopulmonary bypass

Exclusion criteria

• Therapy restricted upon admission
• Preoperative liver or kidney disease or dysfunction
• Preoperative coagulation disorder
• Palliative operation or a second operation
• Type 1 diabetes
• Type 2 diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 2 patient groups

Intensive insulin therapy

Active Comparator group

Description:

Intensive insulin therapy(Blood glucose target: 110-150 mg/dL)

Treatment:

Other: Intensive insulin therapy

Conventional insulin therapy

Active Comparator group

Description:

Conventional insulin therapy(Blood glucose target: 150-180 mg/dl)

Treatment:

Other: Conventional insulin therapy