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

Phase 2

• Conditions: Cardiac Surgery
• Interventions: Other: Intensive insulin therapy; Other: Conventional insulin therapy

• Registration Number: NCT01398722
• Lead Sponsor: Xijing Hospital

Brief 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.

Study Timeline

• Status Verified: 2011-07
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-19
• Last Update Submitted: 2011-07-19
• Study First Posted: 2011-07-20
• Last Update Posted: 2011-07-20
• Study Start: 2011-08
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive insulin therapy	Intensive insulin therapy	Intensive insulin therapy(Blood glucose target: 110-150 mg/dL)
Conventional insulin therapy	Conventional insulin therapy	Conventional insulin therapy(Blood glucose target: 150-180 mg/dl)

Primary Outcome Measures

Name	Time	Method
All cause mortality	one year

Secondary Outcome Measures

Name	Time	Method
Biochemical markers of myocardial injury(troponin and creatine kinase MB)	average 1 month during the hospitalization
Acute renal failure	average 1 month during the hospitalization
Respiratory failure	average 1 month during the hospitalization
ICU and hospital length of stay, and ICU readmissions	average 1 month during the hospitalization
Stroke and reversible ischemic neurologic deficit	average 1 month during the hospitalization
Cardiac Index	average 1 month during the hospitalization
Inotropic Scores	average 1 month during the hospitalization
Perioperative complications	average 1 month during the hospitalization	Perioperative complications including sternal wound infection (deep and superficial), bacteremia, pneumonia, and major cardiovascular events (acute myocardial infarction, congestive heart failure, and cardiac arrhythmias

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China